Pharma Pathway Sop

List of Standard Operating Procedure (SOPs) in Production – Oral
1. Entry and Exit procedure

2. Drain Point numbering, cleaning and sanitization
3. Transfer of finished goods to FG Store
4. Product Change Over
5. Issuance of extra packing material
6. SOP on procedure for blend division
7. Preventive measure to be taken during power failure
8. SOP on control contamination
9. Handling of dispatched packing material
10. Cleaning and operation of 2 D bar coding and scanning system
11. Operation and cleaning of scrubber drier make roots scrub
12. Control of contamination
13. Operation and cleaning of electronic weighing balance
14. Generation of shipper label/ pallet label for track and trace system using bar code
technology as per SSCC code following GSI global standards
15. Batch packing
16. Return of excess primary and secondary packing material
17. Inspection of sieves and screens
18. Operation and cleaning of vibro sifter
19. Operation and cleaning of comminuting mill
20. Operation and cleaning of co-mill
21. Operation and cleaning of Fluid Bed Dryer/ Processor
22. Operation and cleaning of cage blender
23. Operation and cleaning of colloidal mill
24. Operation and cleaning of auto coater
25. Operation and cleaning of paste preparation vessel
26. Operation and cleaning of roll compactor
27. Operation and cleaning of air jet cleaning machine
28. Operation and cleaning of tablet compression machine
29. Operation and cleaning of tablet inspection machine
30. Operation and cleaning of capsule filling machine
31. Operation of ring loader
32. Operation and cleaning of de-dusting and polishing machine
33. Operation and cleaning of carton coding machine
34. Operation of air shower
35. Handling of filters
36. Cleaning of cartridge filter
37. Operation of turn table
38. Handling for FBD bags
39. Operation and cleaning of metal detector
40. Operation and cleaning of oscillating granulator
41. Procurement, inspection, cleaning and usages of dies and punch
42. Preparation and usage lacquer solution
43. Cleaning and preservation of sealing rollers and plates
44. Operation and cleaning of blister packing machine
45. Operation and cleaning of paste kettle
46. Mainating product yield record batch wise
47. Handling of scrap
48. Cleaning of primary production area
49. Handling of change parts
50. Inventory, storage, issuance, usage and destruction of rubber stereo
51. Counting of tablets and capsules by weight for bulk packing
52. Operation and cleaning of shrink warping machine
53. Operation and cleaning of wet and dry vacuum cleaner
54. Cleaning of accessories
55. Cleaning of SS trolleys and pallets
56. Procedure for manual coding
57. Procedure of de-foiling
58. Visual inspection
59. Operation and cleaning of Bin Washing system
60. Operation and cleaning of semiautomatic counting machine
61. PLC operation of tablet compression machine
62. Sieve and screen numbering
63. Cleaning and operation of desiccant inserter
64. Cleaning and operation of cotton inserter
65. Destruction of packing waste generated during packing operation
66. Handling of contract employees for manufacturing and packing activities
67. Handling off line packing
68. Repacking
SOP For Cleaning of Primary Production Area
1.0 Objective:
To lay down a procedure for cleaning of the Primary Production Area.
2.0 Scope
2.1 This SOP is Applicable for cleaning of the Primary Production Area.The Primary Production
Area is
The Primary Production Area is divided in four parts for the purpose of cleaning:
2.1.1 Processing Rooms
2.1.2 Production Corridor Area
2.1.2 Production Corridor Are
2.1.3 Equipment wash area
2.1.4 Semi finished Product storage area and other areas.
3.0 Responsibility
3.1 Housekeeping Person, Operator, Production Officer.
4.0 Accountability
4.1 Production Head.
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No. : Number
SS : Stainless Steal
% : Percent
6.0 Procedures:
6.1 Cleaning aids:
6.1.1 Dry Vacuum Cleaner : It is used for dry cleaning.
6.1.2 Dry wet vacuum cleaner : It cleans and driers the floor at a time (small area)
6.1.3 Scrubber cum dryer : It cleans and driers the floor at a time
6.1.4 Duster Cloth : For cleaning
6.1.5 Domex / Lysol. : Disinfectant
6.1.6 Aluminum Stick Mop. : For ceiling and wall cleaning
6.1.7 Pipe brush : For floor cleaning
6.1.8 Floor cleaning trolley : For moping of pipe brush
6.1.9 Nylon Broom : For cleaning of change room and packing hall.
6.2 Processing Room
6.2.2 The Processing Room shall be cleaned either at the end of a batch or at the end of the day,
which ever is earlier. There are three types of cleaning:
6.2.2.1 Type-A: Applicable for Product to Product change over.

6.2.2.2 Type-B: Applicable for Batch to Batch change over of the same product/if no activity is
present.
6.2.2.3 Type-C: Applicable for the processing rooms which are not used during the day
otherwise the same batch is going on for the next day.
6.3 Type- A Cleaning
6.3.1 Start cleaning of the area after the cleaning of the equipments.
6.3.2 Start the cleaning operation of ceiling and then to walls from top progressing to
downwards.
6.3.3 Clean the door and window glasses using (Disinfectant solution) wet duster.
6.3.4 Clean the doors, door closures, handles and all the hinges of the door using dry followed by
wet and again with dry duster.
6.3.5 If weighing balance is present in the processing room, clean it by using wet duster followed
by dry duster.
6.3.6 Clean the pallets, trolleys, etc using a wet duster followed by a clean dry duster.
6.3.7 Remove the dust from the switchboards, utility pendants using the vacuum cleaner and
wipe with clean dry duster.
6.3.8 Clean the SOP stand using clean dry duster.
6.3.9 Clean the accessories box using the wet duster followed by clean dry duster.
6.3.10 Clean the ceilings of Air Handling Unit (AHU) supply grilles with a pipe brush and
vacuum cleaner during a product change over.
6.3.11 Clean and mop the entire floor twice using 1.0% disinfectant solution (Domex / Lysol)
using Aluminum stick mop / Scrubber cum drier.
6.3.12 Clean the tube light fixtures using wet duster followed by a clean dry duster.
6.3.13 Clean the coving, corners of the entire area using wet (with disinfectant) duster.
6.3.14 Clean the walls of the entire area using (with disinfectant) wet mop.
6.3.15 Collect all the waste from the waste bin into a poly bag and send to the scrap room.
Sanitize the waste bin with (Disinfectant solution) wet duster followed by dry duster.
6.3.16 Clean the drain parts and drain using 1% Disinfectant solution and 10% sodium
Hypochloride solution once a week as per respective SOP scrubbing with scotch brite followed
by sufficient quantity of water. Pour 0.5 liters of 1% disinfectant solution into the drain. Close
the drain with drain trap, perforated plate and lid.
6.3.17 Enter the cleaning details in the ‘Primary Production area cleaning Record’ as per
Annexure No.-I
6.4 Type-B Cleaning:
6.4.1 Follow the steps 6.3.2 to 6.3.9 for cleaning of Processing Room.
6.4.2 Collect all the waste from the waste bin into a poly bag and send to the scrap room. Clean
the waste bin with a dry duster.
6.4.3 Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol.) using
Aluminum stick mop / Scrubber cum dryer.
Annexure No.-I
6.5 Type -C Cleaning:
6.5.1 Clean the doors, door closures, handles and all the hinges of the doors using wet and dry
duster.
Annexure No.-I
6.6 Production Corridor Area
6.6.1 Doors, door closures, handles window glasses, fire extinguishers, emergency lights,
switchboards, coving, corners of the entire area cleaned daily.
6.6.2 Clean and mop the entire floor twice a day.

6.6.3 Tube light fixture, walls, ceiling and corner angle cleaned once a week.
duster.
6.6.6 Clean the fire extinguishers, emergency lights using dry duster.
6.6.7 Clean the switchboards using dry duster.
6.6.9 Clean the ceiling, walls and corner angles using wet duster followed by dry duster. (Once a
week).
6.6.10 Clean the tube lights fixtures using dry duster (Once a week).
6.6.11 Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol)
using Scrubber cum dryer / Aluminum stick mop at the start and at the end of the shift or as
and when required.
6.6.12 Enter the cleaning details in the ‘Semi Finish Product Storage Area, Production Corridor
Area and Equipment Wash Area Cleaning Record’ as per Annexure No.-II
6.7 Equipment wash area
6.7.1 Door, door closures, handles window glasses, emergency lights, switchboards, coving,
corners and drain point of the entire area cleaned daily.
6.7.3 Tube light fixture cleaned once a week.
6.7.4 Clean the door, window glasses, handles and all the hinges of the doors using (Disinfectant
solution) wet duster.
6.7.5 Clean the table using (Disinfectant solution) wet duster followed by dry duster.
6.7.7 Clean the switchboards, utility pendants using clean dry duster.
6.7.9 Clean the waste bin using wet duster followed by dry duster.
6.7.11 Cleaning of covings, corners and walls of the entire area using (Disinfectant) wet duster
Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol) using
Aluminum stick mop .
6.7.12 At the end of the working shift, clean the drain parts and Pour of 10% Hypochloride
solution into the drain. Scrubbing with scotch brite followed by sufficient quantity of water.
Close the drain with drain trap, perforated plate and lid.
Area and Equipment Wash Area Cleaning Record’ as per Annexure No.-II.
6.8 Semi finish Product storage area and other areas:
6.8.1 Semi finish product storage area include semi finish quarantine-I & II, Granules quarantine
I & II and other areas are days packing store, Genitor room, scrap.room and tool rooms.
6.8.1 Door, door closures, handles window glasses, emergency lights, switchboards, SS
containers, coving, corners and drain point of the entire area cleaned daily.
6.8.8 Clean the pallets, trolleys, SS containers, In-process Containers etc using a clean dry
duster.
6.8.9 Clean the coving, corners of the entire area using wet (with Disinfectant) duster.
6.8.10 If the weight balance is present in Semi finish Product storage area clean it using wet
duster followed by dry duster.
6.8.11 Clean the ceiling, walls and corner angles using wet duster followed by dry duster.(once a
week)
6.8.12 Clean the tube lights fixtures using wet duster followed by dry duster.( once a week)
6.8.13 Clean and mop the entire floor using 1% disinfectant solution(Domex / Lysol) using
scrubber cum dryer / Aluminium stick mop at the start and at the end of shift or as and when
required.
6.8.14 Enter the cleaning details in the ‘Semi Finish Product Storage Areas, Production Corridor
Area and Equipment Wash Area Cleaning Record’ as per Annexure No. -II
7.0 Forms and Records (Annexures)
 Processing room cleaning record – Annexure-I

 Semi Finish Product Storage Areas, change part room , Production Corridors Area And
Equipment Wash Area Cleaning Record –
Annexure-II
8.0 Distribution
 Master copy – Quality Assurance

 Controlled copies- Quality Assurance, Production, Housekeeping
9.0 History
Date Revision Number Reason for Revision

– – New SOP
Annexure-I
Processing Room Cleaning Record
Area:______________________
Disinfectant solution used: _____________________ Type of cleaning: A

/B /C
Date Date Date Date Date Date

Sr. No. Area Shift Shift Shift Shift Shift Shift
1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
1 Wet Granulation
2 Dry Granulation I
3 Dry Granulation II
4 Blending Room
5 Capsule Filling- I
6 Capsule Filling- II
7 Tablet Compression I
8 Tablet Compression II
9 Tablet Inspection
10 Coating
S.n. Area 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
11 Strip Packing
12 Blister Packing
13 Alu-Alu Packing
14 De-cartoning Room
15 Air Jet Cleaning
Dry Syrup Filling and
16
Sealing
17 Bulk Packaging Room
Done By (House Keeping
18
Person)
19 Done By (Operator)
20 Checked By
Note: Write A/ B/ C wherever applicable and write N.A. if not applicable.
Type-A: Applicable for Product to Product change over
Type-B: Applicable for Batch to batch change over of the same product.
Type-C: Applicable for the processing rooms which are not used during the day otherwise the
same batch is going on for the next day.
Annexure-II
Semi Finish Product Storage Area, Change Part Room, Production Corridor Area and
Equipment Wash Area Cleaning Record
Area:______________________ Disinfectant solution used:

__________________

Sr.
Area Shift Shift Shift Shift Shift Shift
No.
1 Cleaning of door and
window glasses using
(disinfectant solution) Wet
duster
Cleaning of doors, door
closures, handle and all
2 hinges of doors using dry
duster followed by wet and
again dry duster.
Cleaning of weighing
3 balance using wet duster
followed by dry duster.
Cleaning of pallets and
4 trolleys using wet duster
S.N Area 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
Cleaning of switch boards and
utility pendent using vacuum
5
cleaner and wipe with dry
duster.
Cleaning of SOP stand using
6
clean dry duster.
Cleaning of entire floor using
7
2.5 % disinfectant solution.
Cleaning of coving, corner of
8 entire area using
(Disinfectant) wet duster.
Clean the tube light fixture
9 using wet duster followed by
a clean dry duster.
Done by (House keeping
10
person)
12 Checked By
Note: Write N.A. wherever not applicable. [√] Tick mark if the activity is performed.
SOP for Entry and Exit Procedure into Sampling Booth Area
1.0 Objective
To lay down an Entry and exit procedure for personnel into sampling booth area.
2.0 Scope
This procedure is applicable for entry and exit into sampling booth area.
3.0 Responsibility
QC Chemist or above
4.0 Accountability
Head – Quality Control
SOP : Standard Operating Procedure; a document where step by step

instructions are cited to serve as support for methods or
manners of fulfilling a function or functions reliably and
consistently.
QC : Quality Control
SG : Sub General
GMP : Good Manufacturing Practices
GLP : Good Laboratory Practices
6.0 Procedure
6.1 Entry Procedure into Sampling Booth Area:
6.1.1. Enter into the personnel air lock area.
6.1.2. Take clean secondary gown.
6.1.3. Wear headgear and then wear secondary gown over the Primary gown.
6.1.4. Wear booties.
6.1.5. Sanitize the hands, using disinfectant provided in the change room.
6.1.6. Enter into the Sampling booth area.
6.1.7. Hand gloves shall be used during sampling operation.
6.2 Exit Procedure from Sampling Booth Area:

6.2.1. Before exit, enter into the change room from sampling booth area and discard the hand
gloves in the waste bin.
6.2.2. Ensure sampling booth area has been cleaned as per SOP No. QC-SG-012 (SOP on
Cleaning of Sampling Booth Area).
6.2.3. Remove and keep Headgear, booties and secondary gown in the used gown bin.
6.2.4. Exit through the personnel air lock.
6.2.5. Status of the activity shall be mentioned on status board fixed on outside personnel air lock
area as per Annexure No. (—–)
Activity Status Label – Annexure -I
8.0 References (if any):
8.1 (SOP on cleaning of sampling booth area
9.0 Distribution
Master copy – Quality Assurance
Controlled copies – Personnel & Administration, Quality Assurance, Warehouse RM (display &

record).
10.0 History

Annexure-I (Activity Status Label)
Company Name & Location

Logo
Activity Status
Area
Status
Sign & Date
Format No.:
SOP on Control of Sieves and Screens
1.0Objective:To lay down a procedure for Control of Sieves and Screens of different
Equipments.
2.0Scope
This Standard Operating Procedure is applicable for formulation plant of pharmaceutical

company.
3.0Responsibility
3.1Production Supervisor / Officer shall be responsible for implementation of the procedure as

per this SOP.
3.2Head-Production / designee shall be responsible for compliance of this SOP.
4.0Abbreviations and Definitions
SS :Stainless Steel
BSS :British Standard Sieve
BIS :Bureau of Indian Standard
ISO :International Organization for Standardization
SOP:Standard Operating Procedure
MM :Material Management
QA :Quality Assurance
5.0Procedure
5.1INDENT OF SIEVES AND SCREENS:
5.1.1Sieves and Screens shall be indent as per required sieve number and screen size.
5.1.2Indent shall be raised by Production Supervisor / Officer.
5.1.3Indent for the sieves and screens shall be made as per coding specification.
5.1.4Indent shall be approved by Head-Production/designee and submit to MM department.
5.1.6MM department shall send the purchase order to the manufacturer.
5.2INSPECTION ON RECEIPT:
5.2.1Number of Sieves and Screens received, shall be checked as per Purchase Order.
5.2.2Sieves and Screens Coding shall be checked as per Purchase Order.

5.2.3Integrity of Sieves and Screens shall be checked by Nominal Aperture Calibrator with
Magnification.
5.2.4For the mesh size less then 40 the calibrator shall be placed on the wire mesh and the
individuals Opening is visualized by using the fine tunings.
5.2.5The distance between adjacent parallel wire (Nominal Aperture) is measured in both wrap
and weft direction.
5.2.6Ten such readings shall be taken all over the mesh
5.2.7The average of these readings shall be the nominal aperture of the wire mesh.
5.2.8The nominal aperture size shall be compared with the standard size specified in Annexure-3
and Annexure-4 and if it falls within the specified tolerance the sieve is accepted.
5.2.9For the mesh size 40-200. The calibrator shall be placed on the wire mesh and count the
number of wires in 2.5 mm.
5.2.10Multiply the counted number of wires with 10 it gives the number of wires in a linear inch,
i.e. 25.4mm.
5.2.11The wire diameter of a particular mesh shall be taken from Annexure-VII.
5.2.12The nominal aperture size of the wire mesh shall be calculated by using the formula given
below.
D = Diameter of wire
N = Mesh count = Number of wires/linear inch
Nominal Aperture size = (25.4/N)-D.
5.2.13All the screens and sieves shall be of SS 316 material of construction with lead free
welding (e.g. argon arc welding) and shall comply with BIS / ISO / BSS or Pharmacopoeial
standard.
5.2.14On receiving new sieve / screen entry shall be made in Change Parts Register as per
Annexure-1.
5.2.15Each sieve shall be coded with Identification Number either engraved / written on its SS
parts or silicon part, or shall be labelled (written) under the transparent silicon or Teflon ring.
5.2.16For numbering of the sieve or screen, first two letters shall represent the type of equipment
then a ‘dash’ then size of the mesh in three digits again ‘dash’ and finally serial number in three
digits.
5.2.17The identification number for the sieves or screen of the equipment shall be as following:
Fisrt two digits shall denote name of the equipment like MS for Machenical Sifter
Third digit shall denote dash (-)
Fourth, fifth and Sixth digit shall denote mesh size e.g. For mesh size 5 shall be written as 005
Seventh digit shall denote dash (-)
Eight, ninth and tenth digit shall denote serial number of the sieve / screen.
5.2.18Machenical Sifter / Sifter: The numbering shall start with abbreviation of MS as

equipment name, then sieve size in number (in the case of wire mesh) and finally serial number
of the sieve e.g.
Sieve with sieve size of 8 mesh shall be numbered as
MS-008-001, MS-008-002 etc.
Sieve with sieve size of 100 meshes shall be numbered as
MS-100-001, MS-100-002 etc.
5.2.19Each sieve / screen shall be certified by its manufacturer for its material of construction,
sieve no., and sieve size.
5.2.20Record of the sieves / screen and their identification numbers shall be maintained in
Change Parts Register (Annexure-I)
5.2.21In case any damage is observed during inspection prior to use , the same sieve / screen
shall be immediately discarded by marking ‘Rejected’ with a permanent marker on its ring duly
signed by Production Supervisor / Officer with date. Rejected sieve / screen shall be sending to
Engineering Department for disposal after affixing the label ‘SCRAP ITEM’ duly filled and
singned by Production Supervisor / Officer.
5.2.22After use sieve / screen shall be cleaned along with its parent equipment considering it a
part of parent equipment comply its SOP and after cleaning cover with the stretch wraps and
keep in the sieve storage area.
5.2.23Sieve / Screen Status Register shall be maintained as per Annexure-II.
6.0Forms and Records
6.1Sieves / Screen Inventory Register -Annexure-I
6.2Sieves / Screen Status Register -Annexure-II

6.3Tolerance on Aperture Width -Annexure-III
6.4Sieve/Screen Inspection record -Annexure-IV
6.5Standard Wire Diameter and Permissible Variations -Annexure-V
7.0Distribution
7.1Master Copy – Documentation Cell (QA)
7.2Controlled Copies – Production, Quality Assurance, Administration and Engineering.
 History
Date Revision Number Reason for revision
New
– 00
SOP
Annexure-I
Sieves / Screen Inventory Register
Mother
Bill No. or Assigned Remarks
Supplier Item Equipment Signature
Date Invoice No. Quantity Identification OK / Not
Name description Name & ID & Date
with date Number OK
Number
Annexure-II
SIEVES / SCREENS STATUS REGISTER
Mother Equipment Name: ……………………………
Mother Equipment Identification Number: …………… Date …………………
Total
rejected Quantity Sent for Sent for
S. Identification Total Checked
Description quantity Left in disposal disposal
No. Number quantity By
in Numbers (date) (By)
numbers
Annexure-III
Tolerance on Aperture Width
Tolerances Of Average Aperture In

Nominal Aperture Width In Micrometers
Percentage
I000 to 500 microns + / – 5%
400 to 200 microns + / – 6%
I60 to 100 microns + / – 7%
80 microns + / – 8%
63 microns + / – 9%
50 microns + / -10%
40 microns + / – 11%
32 microns + / – 13%
25 microns + / – 15%
20 microns + / – 17%
Annexure- IV
Standard Wire Diameter and Permissible Variations

Wire Diameter In Tolerance on Wire
Sieve Size Mesh
Microns Diameters
4.75 mm 4 1016 -15 % to +30 %
3.35 mm 6 914 -15 % to +30 %
2.80 mm 7 813 -15 % to +30 %
2.36 mm 8 711 -15 % to +30 %
2.00 mm 10 508 -15 % to +30 %
1.70 mm 12 416 -15 % to +30 %
1.40 mm 14 416 -15 % to +30 %
1.18 mm 16 375 -15 % to +30 %
1.00 mm 18 375 -15 % to +30 %
850 microns 20 416 -15 % to +30 %
710 microns 24 345 -15 % to +30 %
600 microns 30 254 -15 % to +30 %
500 microns 36 193 -15 % to +30 %
425 microns 40 213 -15 % to +30 %
355 microns 44 233 -15 % to +30 %
300 microns 50 193 -15 % to +35 %
250 microns 60 172 -15 % to +35 %
212 microns 70 152 -15 % to +35 %
180 microns 80 132 -15 % to +35 %
150 microns 100 101 -15 % to +35 %
125 microns 120 81 -15 % to +35 %
106 microns 150 61 -15 % to +35 %

90 microns 170 61 -15 % to +35 %
75 microns 200 50 -15 % to +35 %
Annexure -V
Sieve/ Screen Inspection Record
Date___________________ Sieve / Screen Size No________________
Supplier Name___________ Received By_________________________

Size of
Location Av .Size
Sieve/Screen.
1 2 3 4 5 6 7 8 9 10

Inspected By /Date —————–
Entry and Exit Procedure in Pharmaceuticals
Learn the Gowning and entry exit procedure through change rooms.
Color coding of uniform
For first change room
White – All staff (QC, QA, Production & office staff)
Brown – Engineering
Steel Gray – Ware house
For visitors moss green and disposable garments.
For primary change room (Manufacturing, dispensing and sampling)
Sky blue Lint free – All personal and visitors except engineering department
employee
Brown Lint free – Employees of engineering department
The pictorial diagram of gowning procedure and mirror should be displayed in change room.
First change room (male and female)
1. Pull the door of First change room.

2. Remove your street shoes and unwanted articles like wrist watch, mobile phone,
ornaments/jewelry (chain, ring) and keep them in assigned lockers.
3. Wear black clored socks and shoes are provided by factory daily.
4. Take your protective garments like apron, cap from the lockers and wear them are
provided by factory Monday or Tuesday or earlier if required.
5. Through mirror check out your proper gowning.
6. Provide shoes with socks or shoe cover to visitor.
7. Disposable garments may be provided to employee whenever required.
1. Employee working in manufacturing and primary packing area will enter into primary
change room.
2. Changeover of each product uniform shall be change.
3. Remove first change shoes and keep into the locker.
4. Sanitize hand with sanitizer.
5. Cross the COB.
6. Take your lint free garments like apron, cap from the lockers and wear them are provided
by factory Monday or Tuesday or earlier if required.
7. Wear garments over the previous uniform.
8. Wear clean brown colored shoes through the locker.
9. Brown show or additional show cover for visitor.
11. Sanitize your hand with hand sanitizer.
12. Then go to respective work place such as dispensing, sampling, granulation,
compression, coating, capsule manufacturing, and primary packing.
13. Wear mask before entry in core area (Manufacturing) and primary packing.
Exit from primary change room
1. Remove lint free uniform including cap and put them in the lockers.
2. Remove primary shoes and socks and place on the locker.
3. Cross over the bench.
4. Now wear first change shoe.
Exit from first change room
1. Remove first change room uniform and shoes and keep in the lockers.
2. Dispose off all disposal garments and shoe cover in the waste bin
3. After working hours drop factory socks in socks bin which placed in the first change
room.
4. Now wear your street shoes and collect all your belongings.
Precaution
1. At the time of entering toilet, remove first change shoes and wear separate footwear
which provided by factory.
2. Coming out of the toilet again wear first change shoes.
Production
 SOP for Entry and Exit Procedure for Personnel in the Factory Premises
 List of Standard Operating Procedure (SOPs) in Production – Oral
 SOP on Movement of Man and Materials in Production Area
 Tablet Making – Common Problems And Solutions…………basic understanding wrt
practical aspect
 TABLET DEFECTS AND IT’S REMEDIES………Holistic approach..!!!
 Pharmaceutical Stainless Steel – Types, Composition & Difference
 Lyophilization
 Basics of Tablet tooling……(Terminology & specifications)
 TABLET FORMATION PROCESS…..Scientific approach!!!
 Preservatives Used in Pharmaceutical Industry
 Cleaning and Fumigation of Non-Sterile Areas
 SOP for Calibration Of Coating Pan For Rotations Per Minute
 Drain Point Cleaning & Sanitization
 Establishing the minimal and maximal optimum speed during qualification of blender
 Fluidized Bed Dryer and Bag Filters
 Preventive Maintenance Program
 In-Process Checks (Stage – Dry Syrup Packing)
 Different Types of Temperature Sensors
 HVAC (Heating, Ventilation and Air Conditioning) : An Overview
 Tablet Quality—-Issues of mfg and solution
 Tooling inspection lab…..Compression
 Critical Quality attributes for tablet process parameters—
 Trouble shootings of tablet tooling…Tooling Damage and Wear..!!!
 Tablet Tooling basis overview !!!
 Tablet, Mechanical Theory……Bonding In Tablet..!!!
 Physics of Tablet Compression….A holistic approach..!!!
 Process Flow of Oral Solid Dosage Formulation…!!! Basic Understnding
 Tablet Tooling Design—-Technical Perceptive a wide approach…!!!
 SOP For Cleaning of Primary Production Area
 Binder Concentration in Tablet Manufacturing
 Filtration
 Defects of Tablets during Compression
 SOP For Bowie Dick Test
 SOP on Control of Sieves and Screens
 Pressure Differential in Pharma Manufacturing Area
 Film Coating Process of Tablet in Pharmaceutical Manufacturing
 Working and principle of Rapid Mixer Granulator (RMG)
 Working and Principle of colloidal Mill
 Working and Principle of Tablet Compression Machine
 SOP for Entry and Exit Procedure in Aseptic area
 SOP for Entry and Exit Procedure in Production Area
 SOP for Entry and Exit Procedure into Sampling Booth Area
 Entry and Exit Procedure in Pharmaceuticals
 Capacity Calculation of Coating Machine
SOP for Entry and Exit Procedure for Personnel in the Factory Premises
1.0 Objective
1.1 To lay down an Entry and exit procedure for personnel in the factory premises.
2.0 Scope
2.1 This SOP is applicable for entry and exit of personnel.

3.0 Responsibility
3.1 Security Supervisor/ Officer/ Executive Personnel and Administration are responsible for
compliance of the SOP.
4.0 Accountability
4.1 Head – Personnel and Administration.
Initiator Department : Department who shall initiate the preparation of SOP.

instructions are cited to serve as support for methods or manners of fulfilling a function or
functions reliably and consistently.
QA : Quality Assurance.
COB : Cross over Bench.
6.0 Procedure
6.1 Entry and exit procedure from factory gate to respective job area:
6.1.1 Personnel attending for duty as per respective shift with their own vehicle shall park at
designated place and those coming by factory provided transport shall get down at factory main
entrance gate and enter in to factory.
6.1.2 All the factory Employees shall sign in the attendance register at time office.
6.1.3 All employees shall punch their attendance card in electronic punching machine while
entering in to the factory and at the time of exit.
6.1.4 All employees shall pass through security check point for frisking before going to the
respective department.
6.1.5 Entry and exit of all contractual personnel shall be maintained by security supervisor in
contractual attendance register.
6.1.6 If any employees coming late to factory or leaving early from the factory shall be allowed
only through duly signed gate pass by department head, P&A department and Security
personnel.
6.1.7 If any employee forget to bring or punch their attendance card in punching machine, such
employee shall only be allowed to enter the plant by approved and duly signed miss punch
request by department head, P&A department and Security personnel.
6.1.7 Persons having their lunch box shall keep their lunch box on racks provided in canteen.
6.1.8 All the employees shall follow the SOP for entry and exit procedure of respective area.
6.1.9 At the month end the P& A personnel shall check and verify the attendance data of
electronic machine and shall store month wise.
6.1.10 All the gate pass & miss punch request record shall be kept month wise.
Gate Pass (Late coming / Early going) – Annexure -I
Miss Punch Request – Annexure -II
SOP of SOP.
9.0 Distribution
Controlled copies – Personnel & Administration, Quality Assurance, Production (display &

record).
10.0 History

Annexure -I
Annexure -II
1. Entry and Exit procedure

2. Drain Point numbering, cleaning and sanitization
3. Transfer of finished goods to FG Store
4. Product Change Over
5. Issuance of extra packing material
6. SOP on procedure for blend division
7. Preventive measure to be taken during power failure
8. SOP on control contamination
9. Handling of dispatched packing material
10. Cleaning and operation of 2 D bar coding and scanning system
11. Operation and cleaning of scrubber drier make roots scrub
12. Control of contamination
13. Operation and cleaning of electronic weighing balance
14. Generation of shipper label/ pallet label for track and trace system using bar code
technology as per SSCC code following GSI global standards
15. Batch packing
16. Return of excess primary and secondary packing material
17. Inspection of sieves and screens
18. Operation and cleaning of vibro sifter
19. Operation and cleaning of comminuting mill
20. Operation and cleaning of co-mill
21. Operation and cleaning of Fluid Bed Dryer/ Processor
22. Operation and cleaning of cage blender
23. Operation and cleaning of colloidal mill
24. Operation and cleaning of auto coater
25. Operation and cleaning of paste preparation vessel
26. Operation and cleaning of roll compactor
27. Operation and cleaning of air jet cleaning machine
28. Operation and cleaning of tablet compression machine
29. Operation and cleaning of tablet inspection machine
30. Operation and cleaning of capsule filling machine
31. Operation of ring loader
32. Operation and cleaning of de-dusting and polishing machine
33. Operation and cleaning of carton coding machine
34. Operation of air shower
35. Handling of filters
36. Cleaning of cartridge filter
37. Operation of turn table
38. Handling for FBD bags
39. Operation and cleaning of metal detector
40. Operation and cleaning of oscillating granulator
41. Procurement, inspection, cleaning and usages of dies and punch
42. Preparation and usage lacquer solution
43. Cleaning and preservation of sealing rollers and plates
44. Operation and cleaning of blister packing machine
45. Operation and cleaning of paste kettle
46. Mainating product yield record batch wise
47. Handling of scrap
48. Cleaning of primary production area
49. Handling of change parts
50. Inventory, storage, issuance, usage and destruction of rubber stereo
51. Counting of tablets and capsules by weight for bulk packing
52. Operation and cleaning of shrink warping machine
53. Operation and cleaning of wet and dry vacuum cleaner
54. Cleaning of accessories
55. Cleaning of SS trolleys and pallets
56. Procedure for manual coding
57. Procedure of de-foiling
58. Visual inspection
59. Operation and cleaning of Bin Washing system
60. Operation and cleaning of semiautomatic counting machine
61. PLC operation of tablet compression machine
62. Sieve and screen numbering
63. Cleaning and operation of desiccant inserter
64. Cleaning and operation of cotton inserter
65. Destruction of packing waste generated during packing operation
66. Handling of contract employees for manufacturing and packing activities
67. Handling off line packing
68. Repacking
SOP on Movement of Man and Materials in Production Area

1.0 Objective
To lay down a procedure for Movement of Man and Materials in Production area.
2.0 Scope
This standard operating procedure is applicable for Man and Material movement in
pharmaceutical production area.
3.0 Responsibility
3.1 Trained worker / Operator shall be responsible for Movement of material in Production Area
as per this SOP.
3.2 Production Supervisor / Officer, Store Supervisor / Officer shall be responsible for
implementation of this SOP.
3.3 Housekeeping / supervisor shall be responsible for movement of scrap / waste material and
transfer to scrap yard.
3.4 Head Admin shall be responsible for proper movement of scrap.
3.5 Head-Production / Head-Store / designee shall be responsible for compliance of this SOP.
SOP – Standard Operating Procedure
S.S – Stainless Steel
QA – Quality Assurance
IPC – In process containers
FG – Finished Goods
5.0 Procedure
5.1 Raw Material Movement in Production Area
5.1.1 Transfer the issued Raw material in clean S.S. cage / S.S.pellete from store to batch staging
area.
5.1.2 After taking the line clearance of respective areas and equipment’s, verify the weight of the
raw material in batch staging area on pre-calibrated weighing balances. Then transfer the
required raw material lot wise to respective fabrication material air lock/ material air lock for
core corridor (for coating material) in IPC bins / pallets.
5.1.3 Persons shall clean the outer part of IPC bins / pallets and hands aseptically by the
disinfectant with cleaned cloth.
5.1.4 Keep the IPC bins / pellets inside the yellow line in the material air locks.
5.1.5The person keeping the material shall not cross the yellow line.
5.2 Movement of bulk granules in production area
5.2.1 After blending and sampling of material, the materials shall be stored in granules storage
area.
5.2.2 After getting approval from QC for compliance of results and taking the line clearance of
respective compression machine and area, required bins is transfer through the lift into bin feed
area (in case of tablet block).
5.3 Movement of bulk tablet / capsule
5.3.1 After the compression of tablets/coating of the tablets, the tablets shall be stored in HDPE
container and transfer to bulk storage area of the respective block, the same shall be entered in
the inward / outward register.
5.3.2 In case of Capsules: After the filling of capsules, the capsule shall be stored in HDPE
container and transfer to bulk storage area of the respective block, the same shall be entered in
the inward / outward register.
5.4 Movement of bulk Soft Gelatin Capsule in Soft gel block
5.4.1 Movement of bulk of soft gelatin capsules are as under
1. Encapsulation 2. Pre drying 3.Drying 4. Visual Inspection 5.printing 6.Visual Inspection 7.

Bulk storage area 8. Blister Machines 9.material air lock
5.5 Movement of FG for Tablet /Liquid/Soft gel block to FG store
5.5.1 After packing, the finished products shall be transferred from packing area to finished
goods store as per SOP Transfer of Finished products from production to Finished Goods Store.
5.6 Packing Material Movement in production area
5.6.1 Transfer the issued primary packing material with help of SS trolley / cage from the store
to the primary packaging area and secondary packing material to secondary packaging area.
5.6.2 After taking the line clearance of respective machine and area, the machine operator shall
transfer the material to respective area / material air lock under the supervision of production
supervisor / officer.
5.7 Movement of Scrap
5.7.1 Defoiled strips along with empty strips, Blister Machine scrap shall be labeled by
production supervisor / officer and countersigned by IPQA person and shall be transferred
through material air lock.
5.7.2 Rejected Bottles/ROPP caps shall be deformed in filling area and labeled as scrap by
production supervisor / officer and countersigned by IPQA person and shall be transferred to
scrap area.
5.7.3 Trained worker from scrap room shall transfer the checked and labeled poly bags from
material air lock to scrap room and shall shred these materials with the help of shredding
machine.
5.7.4 The shredded material again shall be kept in a poly bag and tightened with a cable tie after
checking from production supervisor / officer and IPQA person.
5.7.5 The shredded material shall be handed over to Admin person through other door of the
scrap room.
5.7.6 Empty drums and rejected bottles, Gelatin Ribbon, waste gelatin mass and other non-
recoverable rejection shall be sent for incineration through scrap room labeled by production
supervisor / officer and countersigned by IPQA person.
5.7.7 The scrap collected in waste bins of production area shall also move out through the scrap
room under the supervision of Admin and Housekeeping supervisor.
5.7.8 Only authorized persons are permitted to enter in Production Area. The persons deployed
for a particular section shall move to that section only.
5.7.9 The areas for storage of materials shall be under lock and key. Any work in these areas
shall be allowed only after permission of respective area in charge.
5.7.10 The bulk storage area and exhibit batches storage area entry / exit shall be recorded in log
sheet, only after permission of respective area in charge.
5.7.11 Designated areas for change parts, dies and punches, sieves shall be controlled through`
respective log sheets/log books.
5.8 Manpower Movement from primary change room to core area and exit
5.8.1 In case of tablet manufacturing, the manpower shall move from primary change room then
outer corridor to secondary change room of respective fabrication area.
5.8.2 In case of compression, coating and blister packing machine the manpower shall move
from primary change room then outer corridor through the secondary change room of core to the
respective area.
5.8.3 In case of packing hall the manpower shall move from primary change room and outer
corridor to the packaging hall directly.
Note: Worker and Supervisor going to batch staging area for verification of issued raw material
shall open the booty and secondary gown in secondary change room of fabrication.
6.0 Forms and Records
Not Applicable
7.0 Distribution
7.1 Master Copy – Documentation Cell (QA)
7.2 Controlled Copies – Production and Quality Assurance.
8.0 History
– 00 New SOP
SOP for Calibration Of Coating Pan For Rotations Per Minute
OBJECTIVE: The objective of this SOP is to provide written guidelines for Calibration Of Coating Pan
For Rotations Per Minute
SCOPE: Scope of this area is limited to Calibration Of Coating Pan For RPM
RESPONSIBILITY: Operator / Pharmacist
PROCEDURE:1) Set the rotations per minute of coating pan at 2 rpm,4 rpm,6 rpm,8 rpm & 12 rpm
respectively
2) Mark one specific point on pan rim by marker.
3) Measure the time (in seconds) by using calibrated stop watch to complete the set rpm
4) Record such three readings for every rpm setting
5) Calculate the average time (Y) (in seconds) required to complete the set rpm
6) Calculate the rpm of coating pan by using formula,
X = set rpm value x 60/ Y
7) Record the observations
Frequency: – once in six months
Tolerance: – +/- 0.5 rotation per minute
SOP For Cleaning of Primary Production Area
1.0 Objective:
To lay down a procedure for cleaning of the Primary Production Area.
2.0 Scope
2.1 This SOP is Applicable for cleaning of the Primary Production Area.The Primary Production
Area is
The Primary Production Area is divided in four parts for the purpose of cleaning:
2.1.1 Processing Rooms

2.1.2 Production Corridor Area
2.1.2 Production Corridor Are
2.1.3 Equipment wash area
2.1.4 Semi finished Product storage area and other areas.
3.0 Responsibility
3.1 Housekeeping Person, Operator, Production Officer.
4.0 Accountability
4.1 Production Head.
No. : Number
SS : Stainless Steal
% : Percent
6.0 Procedures:
6.1 Cleaning aids:
6.1.1 Dry Vacuum Cleaner : It is used for dry cleaning.
6.1.2 Dry wet vacuum cleaner : It cleans and driers the floor at a time (small area)
6.1.3 Scrubber cum dryer : It cleans and driers the floor at a time
6.1.4 Duster Cloth : For cleaning
6.1.5 Domex / Lysol. : Disinfectant
6.1.6 Aluminum Stick Mop. : For ceiling and wall cleaning
6.1.7 Pipe brush : For floor cleaning
6.1.8 Floor cleaning trolley : For moping of pipe brush

6.1.9 Nylon Broom : For cleaning of change room and packing hall.
6.2 Processing Room
6.2.2 The Processing Room shall be cleaned either at the end of a batch or at the end of the day,
which ever is earlier. There are three types of cleaning:
6.2.2.1 Type-A: Applicable for Product to Product change over.
6.2.2.2 Type-B: Applicable for Batch to Batch change over of the same product/if no activity is
present.
6.2.2.3 Type-C: Applicable for the processing rooms which are not used during the day
otherwise the same batch is going on for the next day.
6.3 Type- A Cleaning
6.3.1 Start cleaning of the area after the cleaning of the equipments.
6.3.2 Start the cleaning operation of ceiling and then to walls from top progressing to
downwards.
6.3.4 Clean the doors, door closures, handles and all the hinges of the door using dry followed by
wet and again with dry duster.
6.3.5 If weighing balance is present in the processing room, clean it by using wet duster followed
by dry duster.
6.3.6 Clean the pallets, trolleys, etc using a wet duster followed by a clean dry duster.
6.3.7 Remove the dust from the switchboards, utility pendants using the vacuum cleaner and
wipe with clean dry duster.
6.3.9 Clean the accessories box using the wet duster followed by clean dry duster.
6.3.10 Clean the ceilings of Air Handling Unit (AHU) supply grilles with a pipe brush and
vacuum cleaner during a product change over.
6.3.11 Clean and mop the entire floor twice using 1.0% disinfectant solution (Domex / Lysol)
using Aluminum stick mop / Scrubber cum drier.
6.3.12 Clean the tube light fixtures using wet duster followed by a clean dry duster.
6.3.14 Clean the walls of the entire area using (with disinfectant) wet mop.
Sanitize the waste bin with (Disinfectant solution) wet duster followed by dry duster.
6.3.16 Clean the drain parts and drain using 1% Disinfectant solution and 10% sodium
Hypochloride solution once a week as per respective SOP scrubbing with scotch brite followed
by sufficient quantity of water. Pour 0.5 liters of 1% disinfectant solution into the drain. Close
the drain with drain trap, perforated plate and lid.
Annexure No.-I
6.4 Type-B Cleaning:
6.4.1 Follow the steps 6.3.2 to 6.3.9 for cleaning of Processing Room.
Annexure No.-I
6.5 Type -C Cleaning:
duster.
Annexure No.-I
6.6 Production Corridor Area
6.6.1 Doors, door closures, handles window glasses, fire extinguishers, emergency lights,
switchboards, coving, corners of the entire area cleaned daily.
duster.
6.6.6 Clean the fire extinguishers, emergency lights using dry duster.
6.6.7 Clean the switchboards using dry duster.
6.6.9 Clean the ceiling, walls and corner angles using wet duster followed by dry duster. (Once a
week).
6.6.11 Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol)
using Scrubber cum dryer / Aluminum stick mop at the start and at the end of the shift or as
and when required.
Area and Equipment Wash Area Cleaning Record’ as per Annexure No.-II
6.7 Equipment wash area
6.7.1 Door, door closures, handles window glasses, emergency lights, switchboards, coving,
corners and drain point of the entire area cleaned daily.
6.7.3 Tube light fixture cleaned once a week.
6.7.9 Clean the waste bin using wet duster followed by dry duster.
6.7.11 Cleaning of covings, corners and walls of the entire area using (Disinfectant) wet duster
Clean and mop the entire floor twice using 1% disinfectant solution (Domex / Lysol) using
Aluminum stick mop .
6.7.12 At the end of the working shift, clean the drain parts and Pour of 10% Hypochloride
solution into the drain. Scrubbing with scotch brite followed by sufficient quantity of water.
Close the drain with drain trap, perforated plate and lid.
Area and Equipment Wash Area Cleaning Record’ as per Annexure No.-II.
6.8 Semi finish Product storage area and other areas:
6.8.1 Semi finish product storage area include semi finish quarantine-I & II, Granules quarantine
I & II and other areas are days packing store, Genitor room, scrap.room and tool rooms.
6.8.1 Door, door closures, handles window glasses, emergency lights, switchboards, SS
containers, coving, corners and drain point of the entire area cleaned daily.
6.8.8 Clean the pallets, trolleys, SS containers, In-process Containers etc using a clean dry
duster.
6.8.9 Clean the coving, corners of the entire area using wet (with Disinfectant) duster.
6.8.10 If the weight balance is present in Semi finish Product storage area clean it using wet
duster followed by dry duster.
6.8.11 Clean the ceiling, walls and corner angles using wet duster followed by dry duster.(once a
week)
6.8.12 Clean the tube lights fixtures using wet duster followed by dry duster.( once a week)
6.8.13 Clean and mop the entire floor using 1% disinfectant solution(Domex / Lysol) using
scrubber cum dryer / Aluminium stick mop at the start and at the end of shift or as and when
required.
6.8.14 Enter the cleaning details in the ‘Semi Finish Product Storage Areas, Production Corridor
Area and Equipment Wash Area Cleaning Record’ as per Annexure No. -II
 Processing room cleaning record – Annexure-I

 Semi Finish Product Storage Areas, change part room , Production Corridors Area And
Equipment Wash Area Cleaning Record –
Annexure-II
8.0 Distribution

 Controlled copies- Quality Assurance, Production, Housekeeping
9.0 History

– – New SOP
Annexure-I
Processing Room Cleaning Record
Area:______________________
Disinfectant solution used: _____________________ Type of cleaning: A

/B /C
Sr. No. Area Date Date Date Date Date Date

Shift Shift Shift Shift Shift Shift
1 Wet Granulation
2 Dry Granulation I
3 Dry Granulation II
4 Blending Room
5 Capsule Filling- I
6 Capsule Filling- II
7 Tablet Compression I
8 Tablet Compression II
9 Tablet Inspection
10 Coating
S.n. Area 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
11 Strip Packing
12 Blister Packing
13 Alu-Alu Packing
14 De-cartoning Room
15 Air Jet Cleaning
Dry Syrup Filling and
16
Sealing
17 Bulk Packaging Room
Done By (House Keeping
18
Person)
20 Checked By
Note: Write A/ B/ C wherever applicable and write N.A. if not applicable.
Type-A: Applicable for Product to Product change over
Type-B: Applicable for Batch to batch change over of the same product.
Type-C: Applicable for the processing rooms which are not used during the day otherwise the
same batch is going on for the next day.
Annexure-II
Semi Finish Product Storage Area, Change Part Room, Production Corridor Area and
Equipment Wash Area Cleaning Record
Area:______________________ Disinfectant solution used:

__________________
Sr.
Area Shift Shift Shift Shift Shift Shift
No.
Cleaning of door and
window glasses using
1
(disinfectant solution) Wet
duster
Cleaning of doors, door
closures, handle and all
2 hinges of doors using dry
duster followed by wet and
again dry duster.
Cleaning of weighing
3 balance using wet duster
Cleaning of pallets and
4 trolleys using wet duster
S.N Area 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd 1st 2nd
Cleaning of switch boards and
utility pendent using vacuum
5
cleaner and wipe with dry
duster.
Cleaning of SOP stand using
6
clean dry duster.
Cleaning of entire floor using
7
2.5 % disinfectant solution.
Cleaning of coving, corner of
8 entire area using
(Disinfectant) wet duster.
Clean the tube light fixture
9 using wet duster followed by
a clean dry duster.
Done by (House keeping
10
person)
12 Checked By
Note: Write N.A. wherever not applicable. [√] Tick mark if the activity is performed.
SOP on Control of Sieves and Screens
1.0Objective:
To lay down a procedure for Control of Sieves and Screens of different Equipments.
2.0Scope
This Standard Operating Procedure is applicable for formulation plant of pharmaceutical

company.
3.0Responsibility
3.1Production Supervisor / Officer shall be responsible for implementation of the procedure as

per this SOP.
3.2Head-Production / designee shall be responsible for compliance of this SOP.
4.0Abbreviations and Definitions
SS :Stainless Steel
BSS :British Standard Sieve
BIS :Bureau of Indian Standard
ISO :International Organization for Standardization
SOP:Standard Operating Procedure
MM :Material Management
QA :Quality Assurance
5.0Procedure
5.1INDENT OF SIEVES AND SCREENS:
5.1.1Sieves and Screens shall be indent as per required sieve number and screen size.
5.1.2Indent shall be raised by Production Supervisor / Officer.
5.1.3Indent for the sieves and screens shall be made as per coding specification.
5.1.4Indent shall be approved by Head-Production/designee and submit to MM department.
5.1.6MM department shall send the purchase order to the manufacturer.
5.2INSPECTION ON RECEIPT:
5.2.1Number of Sieves and Screens received, shall be checked as per Purchase Order.
5.2.2Sieves and Screens Coding shall be checked as per Purchase Order.
5.2.3Integrity of Sieves and Screens shall be checked by Nominal Aperture Calibrator with
Magnification.
5.2.4For the mesh size less then 40 the calibrator shall be placed on the wire mesh and the
individuals Opening is visualized by using the fine tunings.
5.2.5The distance between adjacent parallel wire (Nominal Aperture) is measured in both wrap
and weft direction.
5.2.6Ten such readings shall be taken all over the mesh
5.2.7The average of these readings shall be the nominal aperture of the wire mesh.
5.2.8The nominal aperture size shall be compared with the standard size specified in Annexure-3
and Annexure-4 and if it falls within the specified tolerance the sieve is accepted.
5.2.9For the mesh size 40-200. The calibrator shall be placed on the wire mesh and count the
number of wires in 2.5 mm.
5.2.10Multiply the counted number of wires with 10 it gives the number of wires in a linear inch,
i.e. 25.4mm.
5.2.11The wire diameter of a particular mesh shall be taken from Annexure-VII.
5.2.12The nominal aperture size of the wire mesh shall be calculated by using the formula given
below.
D = Diameter of wire
N = Mesh count = Number of wires/linear inch
Nominal Aperture size = (25.4/N)-D.
5.2.13All the screens and sieves shall be of SS 316 material of construction with lead free
welding (e.g. argon arc welding) and shall comply with BIS / ISO / BSS or Pharmacopoeial
standard.
5.2.14On receiving new sieve / screen entry shall be made in Change Parts Register as per
Annexure-1.
5.2.15Each sieve shall be coded with Identification Number either engraved / written on its SS
parts or silicon part, or shall be labelled (written) under the transparent silicon or Teflon ring.
5.2.16For numbering of the sieve or screen, first two letters shall represent the type of equipment
then a ‘dash’ then size of the mesh in three digits again ‘dash’ and finally serial number in three
digits.
5.2.17The identification number for the sieves or screen of the equipment shall be as following:
Fisrt two digits shall denote name of the equipment like MS for Machenical Sifter
Third digit shall denote dash (-)
Fourth, fifth and Sixth digit shall denote mesh size e.g. For mesh size 5 shall be written as 005
Seventh digit shall denote dash (-)
Eight, ninth and tenth digit shall denote serial number of the sieve / screen.
5.2.18Machenical Sifter / Sifter: The numbering shall start with abbreviation of MS as

equipment name, then sieve size in number (in the case of wire mesh) and finally serial number
of the sieve e.g.
Sieve with sieve size of 8 mesh shall be numbered as
MS-008-001, MS-008-002 etc.
Sieve with sieve size of 100 meshes shall be numbered as
MS-100-001, MS-100-002 etc.
5.2.19Each sieve / screen shall be certified by its manufacturer for its material of construction,
sieve no., and sieve size.
5.2.20Record of the sieves / screen and their identification numbers shall be maintained in
Change Parts Register (Annexure-I)
5.2.21In case any damage is observed during inspection prior to use , the same sieve / screen
shall be immediately discarded by marking ‘Rejected’ with a permanent marker on its ring duly
signed by Production Supervisor / Officer with date. Rejected sieve / screen shall be sending to
Engineering Department for disposal after affixing the label ‘SCRAP ITEM’ duly filled and
singned by Production Supervisor / Officer.
5.2.22After use sieve / screen shall be cleaned along with its parent equipment considering it a
part of parent equipment comply its SOP and after cleaning cover with the stretch wraps and
keep in the sieve storage area.
5.2.23Sieve / Screen Status Register shall be maintained as per Annexure-II.
6.0Forms and Records

6.1Sieves / Screen Inventory Register -Annexure-I
6.2Sieves / Screen Status Register -Annexure-II
6.3Tolerance on Aperture Width -Annexure-III
6.4Sieve/Screen Inspection record -Annexure-IV
6.5Standard Wire Diameter and Permissible Variations -Annexure-V
7.0Distribution
7.1Master Copy – Documentation Cell (QA)
7.2Controlled Copies – Production, Quality Assurance, Administration and Engineering.
 History
New
– 00
SOP
Annexure-I
Sieves / Screen Inventory Register
Mother
Bill No. or Assigned Remarks
Supplier Item Equipment Signature
Date Invoice No. Quantity Identification OK / Not
Name description Name & ID & Date
with date Number OK
Number
Annexure-II
SIEVES / SCREENS STATUS REGISTER
Mother Equipment Name: ……………………………
Mother Equipment Identification Number: …………… Date …………………
Total
rejected Quantity Sent for Sent for
S. Identification Total Checked
Description quantity Left in disposal disposal
No. Number quantity By
in Numbers (date) (By)
numbers
Annexure-III
Tolerance on Aperture Width
Tolerances Of Average Aperture In

Nominal Aperture Width In Micrometers
Percentage
I000 to 500 microns + / – 5%
400 to 200 microns + / – 6%
I60 to 100 microns + / – 7%
80 microns + / – 8%
63 microns + / – 9%
50 microns + / -10%
40 microns + / – 11%
32 microns + / – 13%
25 microns + / – 15%
20 microns + / – 17%
Annexure- IV
Standard Wire Diameter and Permissible Variations

Wire Diameter In Tolerance on Wire
Sieve Size Mesh
Microns Diameters
4.75 mm 4 1016 -15 % to +30 %
3.35 mm 6 914 -15 % to +30 %
2.80 mm 7 813 -15 % to +30 %
2.36 mm 8 711 -15 % to +30 %
2.00 mm 10 508 -15 % to +30 %
1.70 mm 12 416 -15 % to +30 %
1.40 mm 14 416 -15 % to +30 %
1.18 mm 16 375 -15 % to +30 %
1.00 mm 18 375 -15 % to +30 %
850 microns 20 416 -15 % to +30 %
710 microns 24 345 -15 % to +30 %
600 microns 30 254 -15 % to +30 %
500 microns 36 193 -15 % to +30 %
425 microns 40 213 -15 % to +30 %
355 microns 44 233 -15 % to +30 %
300 microns 50 193 -15 % to +35 %
250 microns 60 172 -15 % to +35 %
212 microns 70 152 -15 % to +35 %
180 microns 80 132 -15 % to +35 %
150 microns 100 101 -15 % to +35 %
125 microns 120 81 -15 % to +35 %
106 microns 150 61 -15 % to +35 %

90 microns 170 61 -15 % to +35 %
75 microns 200 50 -15 % to +35 %
Annexure -V
Sieve/ Screen Inspection Record
Date___________________ Sieve / Screen Size No________________
Supplier Name___________ Received By_________________________

Size of
Location Av .Size
Sieve/Screen.
1 2 3 4 5 6 7 8 9 10

Inspected By /Date —————–
SOP for Entry and Exit Procedure in Aseptic area
1.0 Objective
To lay down a procedure for entry, exit and gowning procedure in aseptic area.
2.0 Scope
This SOP is applicable for only qualified persons for entry, exit and gowning in aseptic area
3.0 Responsibility
Officers or above – Production
4.0 Accountability
Production Head.

S.S. : Stainless Steel
6.0 Procedure
6.1 Checks:
6.1.1 Entry to the aseptic area is restricted to authorized qualified personnel only as per the list of
authorized and qualified personnel displayed on the entry of aseptic area.
Persons suffering from any infectious, ailments like cold, cough, fever, injury or any other
diseases etc are not allowed to enter the aseptic area.
Persons with unhygienic conditions are not allowed to enter the aseptic area.
Females are not permitted to enter the aseptic area.
6.2 Entry into sump area:
Press the door-interlocking button, open the door and enter the sump area.
Remove the plant footwear and keep them in provided shoe rack inside the almirah.
Remove the plant uniform.
Keep the uniform in the almirah.
6.3 Entry into first change room:
Press the door-interlocking button, open the door with elbow and enter the first change room.
Fill the SS mug with disinfectant solution (Kept in SS container), Keep feet in SS tray and pour
the disinfectant solution on to feet. Ensure that the solution dose not splash out of tray.
Step on the protect mat provided in the change room.
Rinse the hands with disinfectant solution
While disinfecting the hands, ensure that disinfectant solution should not splash on the floor.
Take the clean primary garment from almirah (shirts, trousers, caps & booty)
Wear the cap.
Wear shirt and then trouser. While wearing the trouser ensure that it does not touch the floor.
Tuck the shirts in trouser.
Wear the booties.
6.4 Entry into second change room:
Press the door-interlocking button, open the door with elbow and enter the second change
room.
Sanitize the hands with disinfectant solution
Take the pre-sterilized hand gloves (8”) kept in S.S. perforated box
Wear the hand gloves, while wearing the hand gloves ensure that outer surface of the gloves
should not touch with bare hands and sanitize it
6.5 Entry into third change room
Press the door-interlocking button, open the door with elbow and enter the third change room.
Open the garment cubicle and take the bag consisting of sterile secondary garment
Wear the garment in following sequence strictly
Wear the headgear without touching the outer surface
Wear the boiler suit by taking care to avoid contact with floor. Ensure that loose ends of head
cover are tucked inside the boiler suit. Close the chain of the boiler suit
Pick up one Goggle from the garment storage cubicle and wear in front of the mirror
Sit on the S.S. cross over bench
Tie up one booty and cross the leg on other side of the bench
Tie up the other booty without touching the bench by hand and cross over the bench
Discard the empty bag in the waste bin provided in the change room
Look into the mirror to check the proper gowning and ensure that no body part is exposed
6.6 Entry into the buffer change room

Press the door-interlocking button, open the door with elbow and enter the buffer change room
and stand for a moment
Sanitize the gloved hand with disinfectant solution
Pick up the secondary hand gloves (14”) from the SS box provided and wear over the primary
hand gloves
Sanitize the gloves hand with disinfectant solution
Enter the sterile passage by pushing the door with elbow and stand for a moment
6.7 Entry into cooling zone / vial filling room
Walk slowly and enter the vial filing room by pushing the door with elbow through sterile
passage or cooling zone by pushing the door with elbow
6.8 Entry into sampling room
After coming to sterile passage push the door of sampling area and enter into the Sampling
room
6.9 Exit procedure from aseptic area
6.9.1 Exit from filling room / cooling zone
Press the door-interlocking button and pull the door of filling room or cooling zone and enter
the sterile passage
6.9.2 Exit from the sampling room
Pull the door of sampling room and Enter into the sterile passage
6.9.3 Entry into Exit Buffer room
Press the door-interlocking button and pull the door of exit buffer room
Enter the exit buffer room
Wait for about 30 seconds in the buffer room
6.9.4 Enter into the return change room
Press the door-interlocking button and pull the door of return change room
Enter the return change room

Remove the goggles and keep them S.S. tray for further sanitization
Remove the secondary gloves and dispose them in bin provided
Remove the secondary garments
Keep the head gear, boiler suit and booties in the bin specified there for further washing
and Sterilization
Remove the primary garment
Keep the primary cap, booties, shirt and trouser in the bin specified for further washing
Remove the hand gloves and keep them in bin for disposal
6.9.5 Entry into the sump area
Press the door interlocking button and pull the door of sump area
Enter the sump area
Wear the plant uniform and plant foot wear
6.9.6 Entry into corridor
Press the door interlocking button and push the door of corridor
Enter in the corridor
Declaration Sheet – Annexure I
Entry and exit record of Aseptic area. – Annexure II
SOP of SOP.
9.0 Distribution
Controlled copies – Quality Assurance, Production Aseptic (display & record).

10.0 History

SOP for Entry and Exit Procedure in Production Area
1.0 Objective
To lay down a procedure for plant entry and exit procedure in production area.
2.0 Scope
This SOP is applicable to all plant employee (Gents) entering from primary change rooms.
3.0 Responsibility
Officers or above – Production & Q.A.
 Accountability
Production Head.
 Abbreviations and Definitions

No. : Number
 Procedure
Gowning For Entry
Only authorized personnel are allowed to enter in to the plant.
Swap the card into while entering the change room of production block.
Enter into the Change Room, remove the street foot-wears & keep the street footwear in the shoe
locker provided in the change room.
Wear the plant sleepers and enter in the wash area. Wash and dry the hands and enter into the
change room.
Take the clean plant uniform consisting of pant, shirt and cap from the linen counter provided in
the change room.
Push the door and enter in the primary change room.
Remove the street garments, sleeper and keep in the respective locker.
Step over the bench and wear the plant uniform and another pair of sleeper in the following
sequence: –
Wear the cap.
Wear the pant and shirt.
Wear the plant sleeper.
Observe yourself in the mirror and ensure that hair is completely covered under cap and properly
gowned.
Sanitized the hands with the Sterillium disinfectant.
Enter the plant corridor through the air lock.
From this corridor proceed to respective floor depending upon the nature of job.
De-gowning For Exit
Warehouse & packing persons enter into the exit change room.
Persons who are involved in manufacturing must come through Air Shower for De-Dusting.
Press the push button of door interlock and enter in to the air lock.
Press the push button of door interlock and enter in to the common change room.
Remove the plant uniform and sleeper and put it in the locker provided.
Dispose the plant uniform in the bin provided for further washing at the end of shift and sleeper
kept in locker.
Step over the bench and wear the street clothes from the respective locker.
Push the door and come out from the common change room.
Take out the street footwear from the locker and wear the same.
Deactivate both hands washing with Sterillium.
Use the wash room, wash and dry the hands.
Come out from the plant through plant personnel entry door.
 Forms and Records (Annexures)
Not Applicable
 References (if any):
SOP of SOP.
 Distribution
o Master copy – Quality Assurance
o Controlled copies – Quality Assurance, Production (display & record).
 History

SOP for Entry and Exit Procedure into Sampling Booth Area
1.0 Objective
To lay down an Entry and exit procedure for personnel into sampling booth area.
2.0 Scope
This procedure is applicable for entry and exit into sampling booth area.
3.0 Responsibility
QC Chemist or above
4.0 Accountability

instructions are cited to serve as support for methods or
manners of fulfilling a function or functions reliably and
consistently.
SG : Sub General
6.0 Procedure
6.1 Entry Procedure into Sampling Booth Area:
6.1.1. Enter into the personnel air lock area.
6.1.2. Take clean secondary gown.
6.1.3. Wear headgear and then wear secondary gown over the Primary gown.
6.1.4. Wear booties.
6.1.5. Sanitize the hands, using disinfectant provided in the change room.
6.1.6. Enter into the Sampling booth area.
6.1.7. Hand gloves shall be used during sampling operation.
6.2 Exit Procedure from Sampling Booth Area:

6.2.1. Before exit, enter into the change room from sampling booth area and discard the hand
gloves in the waste bin.
6.2.2. Ensure sampling booth area has been cleaned as per SOP No. QC-SG-012 (SOP on
Cleaning of Sampling Booth Area).
6.2.3. Remove and keep Headgear, booties and secondary gown in the used gown bin.
6.2.4. Exit through the personnel air lock.
6.2.5. Status of the activity shall be mentioned on status board fixed on outside personnel air lock
area as per Annexure No. (—–)
Activity Status Label – Annexure -I
8.1 (SOP on cleaning of sampling booth area
9.0 Distribution
Controlled copies – Personnel & Administration, Quality Assurance, Warehouse RM (display &

record).
10.0 History
Annexure-I (Activity Status Label)
Company Name & Location

Logo
Activity Status
Area
Status
Sign & Date
Format No.:
Entry and Exit Procedure in Pharmaceuticals
Learn the Gowning and entry exit procedure through change rooms.
Color coding of uniform
For first change room
White – All staff (QC, QA, Production & office staff)
Brown – Engineering
Steel Gray – Ware house
For visitors moss green and disposable garments.
For primary change room (Manufacturing, dispensing and sampling)
Sky blue Lint free – All personal and visitors except engineering department
employee
Brown Lint free – Employees of engineering department
The pictorial diagram of gowning procedure and mirror should be displayed in change room.
1. Pull the door of First change room.

2. Remove your street shoes and unwanted articles like wrist watch, mobile phone,
ornaments/jewelry (chain, ring) and keep them in assigned lockers.
3. Wear black clored socks and shoes are provided by factory daily.
4. Take your protective garments like apron, cap from the lockers and wear them are
provided by factory Monday or Tuesday or earlier if required.
6. Provide shoes with socks or shoe cover to visitor.
7. Disposable garments may be provided to employee whenever required.
1. Employee working in manufacturing and primary packing area will enter into primary
change room.
2. Changeover of each product uniform shall be change.
3. Remove first change shoes and keep into the locker.
4. Sanitize hand with sanitizer.
5. Cross the COB.
6. Take your lint free garments like apron, cap from the lockers and wear them are provided
by factory Monday or Tuesday or earlier if required.
7. Wear garments over the previous uniform.
8. Wear clean brown colored shoes through the locker.
9. Brown show or additional show cover for visitor.
11. Sanitize your hand with hand sanitizer.
12. Then go to respective work place such as dispensing, sampling, granulation,
compression, coating, capsule manufacturing, and primary packing.
13. Wear mask before entry in core area (Manufacturing) and primary packing.
Exit from primary change room
1. Remove lint free uniform including cap and put them in the lockers.
2. Remove primary shoes and socks and place on the locker.
3. Cross over the bench.
4. Now wear first change shoe.
Exit from first change room
1. Remove first change room uniform and shoes and keep in the lockers.
2. Dispose off all disposal garments and shoe cover in the waste bin
3. After working hours drop factory socks in socks bin which placed in the first change
room.
4. Now wear your street shoes and collect all your belongings.
Precaution
1. At the time of entering toilet, remove first change shoes and wear separate footwear
which provided by factory.
2. Coming out of the toilet again wear first change shoes.
Quality Control
 SOP on Stability Studies for Drug Products

 Analytical Method of Medicinal Product Starting Generic Name with word “A”
 Changes to USP 38 General Chapter 791 pH
 Significant Change in Pharmaceutical Stability Testing
 SOP on Handling of Out of Trend (OOT)
 Sampling, Preservation and Storage Procedure of Water Sample
 Preparation and Bio-Burden Monitoring of 70% IPA
 SOP for Behavior in Quality Control Department
 Calibration and Handling of Glassware (Class A and Class B)
 SOP on Validation of Microsoft Excel Calculations Worksheets
 List of ICH Quality Guidelines in Pharmaceuticals
 SOP on Sampling Procedure for Purified Water
 Sampling, Preservation and Storage of Water Sample
SOP on Stability Studies for Drug Products
1.0 Objective:
To lay down a procedure for carrying out stability studies of drug products.
2.0 Scope:
This SOP is applicable for carrying out stability studies of drug products of pharmaceutical
formulation plant.
3.0 Responsibility:
QC Chemist or above
4.0 Accountability:
Head – Quality Assurance
5.0 Abbreviation:
 ICH : International Conference on Harmonization

 USP : United State Pharmacopoeia
 QA : Quality Assurance
 QC : Quality Control
 SOP : Standard Operating Procedure
 ACC : Accelerated
 CRT : Controlled Room Temperature
 RH : Relative Humidity
 API : Active pharmaceutical Ingredient
 COA : Certificate of analysis
 R. No. : Analytical Reference Number
 ICDRA : International Conference of drug regulatory authorities
 SG : Sub-General
 GN : General
 SP : Specific
 NA : Not Applicable
 CAPA : Corrective and preventive action
 B. No Batch number
 No.: Number
 Deptt: Department
6.0 Procedure:
6.1 Stability study shall be carried out:
6.1.1 To understand any chemical, physical and microbiological changes in the Drug products
during their shelf life when exposed under different storage conditions.
6.1.2 To confirm that drug products are assured for their efficacy and safety in marketed packs.
6.1.3 To compile data for confirming storage conditions and shelf life for finish products.
6.1.4 In support of product registration in different countries.
6.2 Initially three batches are kept for stability study (Initially “means the product is subjected
for stability for first time at the location”) for long term, intermediate and accelerated stability.
Subsequently minimum one batch per year of each product is subjected for Long Term
condition. These samples shall be packed in marketed packs or simulated marketed packs.
6.3 The sample shall be charged to stability study for following change:-
6.3.1 Change in formulation-Accelerated and Long Term conditions-03 Batches.
6.3.2 Change in manufacturing process-Accelerated and Long Term conditions-03 Batches
6.3.3 Change in source of API-Accelerated and Long Term conditions-01 Batch.
6.3.4 Change in Batch size-Long Term condition-01 Batch.Change in Primary container-closure

system-Accelerated and Long Term conditions –
6.3.5 Change in Primary container-closure system-Accelerated and Long Term conditions –

01Batch
6.3.6 Change in manufacturing equipment (s) having different operating procedure- Accelerated
and Long Term conditions-03 Batches.
6.4 Additional Stability studies may be carried out as per the customer’s requirement based on
the storage conditions and the frequencies of analysis as required by the
6.5 Additional stability studies may also to be carried out as per the directives received from
Head-QA.
6.6 QA shall be responsible to identify reasons for performing stability studies, and shall send
the stability study request as per Annexure No.-I to QC along with samples, placebo and finish
product Certificate of Analysis.
6.7 Samples for stability study shall be collected by QA personnel during packing operation,
representing start, middle and end of packaging.
6.7.1 Sample for stability study shall be charged into proper marketed packs or whenever
necessary shall be charged using simulated packs which is identical to market packs. Label the
samples of accelerated, Intermediate and Long Term condition as per Annexure No.-VI,
Annexure No.- VII and Annexure No.- VIII respectively.
6.7.2 In case of dry powder injection and Dry syrup, half of the sample shall be charged in invert
position and half of the sample in up-position.
6.7.3 Label for accelerated condition shall be in Red colour, Intermediate shall be in Brick colour
and long term shall be in green colour.
6.8 Sample shall be charged to stability chamber within 15 days of release of batch and the
results of initial analysis at the time of release of batch shall be considered as “0” month results.
If this period exceeds 15 days, the sample shall be re-analyzed after allotting AR No. according
to respective SOP treating sample as stability sample before charging to stability study to
generate “0” month results. Sample shall be analyzed before charging to stability chamber for
additional test if any.
6.9 The “Start date” of stability study shall be that date on which sample has been charged in
stability chamber.
6.10 Subsequent time intervals shall be conducted on the basis of start date.
6.11 The due date at each interval (testing station) is the date that the sample shall be removed
from the stability chamber.
6.12 Withdrawal of the stability sample shall be carried out as per monthly planner and Monthly
planner shall be as per Annexure No. – XII. Reconciliation of the same shall be carried out
during the withdrawal of the sample and record of the same shall be maintained as per Annexure
No. – X.
6.13 Sample shall be withdrawn from stability chambers at different testing stations within +5
Days from due date for accelerated, Long Term and Intermediate conditions.
6.14 Place withdrawn sample at room temperature in a cupboard labeled as “Under Test” and
initiate the analysis on the same day of withdrawal.
6.15 Batch specific protocol shall be prepared for performing the stability studies. The protocol
covers stations (time intervals) and tests required during the stability studies of that product.
Stability study protocol shall be prepared as per Annexure No. – XI. Stability Protocol shall be
prepared for all batches, which shall be charged for stability study. Protocol shall be approved by
Head-QA.
6.16 Each stability Protocol number consist of alphanumerical characters and mentioned as SS-
X-YYYY-ZZ.
6.16.1 First “two” (i.e. SS) character indicates code for stability study.
6.16.2 Next character “-“ is a separator.
6.16.3 Next character (i.e. X ) indicates the product code as per respective SOP.
6.16.4 Next Character “-“ is a separator.
6.16.5 Next four character ( i.e.YYYY) indicates the unique number in which first two Character
indicates serial number increases sequencelly for a particular product and last two character
indicate year of preparation.
6.16.6 Next character “-“ is a separator.
6.16.7 Next two character (i.e. ZZ) indicates the version number.
6.16.8 e.g. SS-PARAC-0117-00, in which SS for stability study, PARAC for PARACIN100 mg
Tablets (USP), 01 for serial no. i.e. first protocol for Nepotel100 mg Tablets (USP), 10 for year
2017 and 00 for version number.
6.17 Each stability protocol consist of details as mentioned below:
6.17.1 Subject indicates subject of document i.e. ‘stability protocol’ shall be mentioned in the
same.
6.17.2 Department indicates name of the department preparing the protocol i.e. ‘Quality Control’
shall be mentioned.
6.17.3 Product name indicates the generic name of the product for which the stability protocol
shall be prepared.
6.17.4 Protocol number indicates the stability study protocol number as mentioned in point
number 6.17.
6.17.5 Revision number indicates the version number of the stability study protocol. If it is
prepared for the first time then “00” shall be mentioned. For any subsequent revision, the
revision number “01” shall be mentioned.
6.17.6 Effective date indicates the date of effectiveness of stability protocol.

6.17.7 Supersedes indicates the previous version number. If protocol is prepared first time then
NA shall be mentioned for every subsequent revision the revision number of previous protocol
shall be mentioned.
6.17.8 Revise the protocol if required.
6.18 As per approved protocol, QC department shall charge the stability samples as per
following procedure:
6.18.1 Segregate the packed containers for the stability conditions as mentioned in stability
Protocol.
6.18.2 Affix the stability label as per stability condition as per Annexure No. – VI, VII &
Annexure No. – VIII.
6.18.3 Quantity of sample required for the stability study shall be kept doubled the times of
samples required for one complete analysis or as per specific requirement from customer.
Approximate quantity required on each station has been summarized as per Annexure No. –
XVI.
6.18.4 Charge the packed stability samples into the respective stability chamber. Ensure that door
of stability chamber shall be locked before leaving.
6.18.5 Maintain the details of the product and scheduled station of stability products as per
Annexure No. – II.
6.19 Stability study Conditions / Intervals:
6.19.1 Stability studies shall be conducted at conditions mentioned in table – I (References ICH
(Q1A) and ICDRA) :
Table – I
Stability Type Conditions* Frequency**

Initial & 3,6,9,12,18, 24,36,
Long Term ( Zone-I & Zone-II) 25°C±2°C/60% ± 5% RH
48 months
Intermediate*** ( Zone-I & Zone-
30°C±2°C/65% ± 5% RH Initial & 3,6,9,12
II)
Initial & 3,6,9,12,18, 24,36,
Long term ( Zone IV a ) 30°C±2°C/65% ± 5% RH
48 months
Initial & 3,6,9,12,18, 24,36,
Long term ( Zone IV b ) 30°C±2°C/75% ± 5% RH
48 months
Accelerated Stability 40°C ± 2°C/75 % ± 5% RH Initial & 1,2,3,6 months
* The storage conditions to be decided as per product registration.
** The last frequency for Long term shall be either 12 months after shelf life of the product
or 36 months whichever is greater.
*** Analysis of the intermediate samples shall be done only when samples charged at
accelerated conditions shows a significant change
6.20 After withdrawal of samples, AR No. shall be allotted as per respective SOP and record
shall be maintained as per Annexure No. – XV. Stability sample shall be given to analyst with
worksheet and photocopy of Summary sheet upto pervious station. Stability samples shall be
analyzed as per specification mentioned in the stability protocol of the specific batch.
6.21 Analyst shall record raw data of stability product in respective worksheet as per Annexure
No. – IX for dry syrup / Injection and Annexure No. – VIII & X for Tablets / Capsules. And
result shall be verified by analyst for any OOT or significant change with the help of the
summary sheet upto previous station.
6.22 On Completion of testing after each station, stability data shall be reviewed and these
results summarized in summary sheet for Long Term as per Annexure No. – III, For Intermediate
as per Annexure No. – IV and For Accelerated as per Annexure – V. After that stability data
shall be submitted in QA.
6.23 Inform any significant changes to the Head of Department which is mentioned below :
6.23.1 5% or more than 5% potency changes from the initial assay.
6.23.2 Any specified degradant not meeting specification limit.
6.23.3 pH not meeting specification limit.
6.23.4 Failure to meet specifications for appearance and physical properties i.e. colour, shape,
hardness etc.
6.23.5 Dissolution not meeting specification limit for 12 dosage units.
6.24 Notify any “Out of specification” (OOS) or “Out of Trend” (OOT) results to Head of
Department and perform the investigation as per the relevant SOPs (for handling of Out of
specification, respective SOP and for Handling of Out of trend, respective SOP.
6.25 The stability study shall be discontinued in case of failure to comply the specification.
Stability study discontinuation shall be done as per Annexure No. – XIII after approval of Head-
QA.
6.26 The investigation for failure shall be conducted with the help of Head-QA. Head QA shall
decide whether investigation shall be extended to other batches manufactured under similar
condition and or other batches, which are likely to be affected. Record of the same shall be
maintained as per Annexure No. – XVII.
6.27 Any failure in stability chamber generate an alarm on stability chamber as well as on
security gate. At the time of duty hours stability In-charge shall rectify the problem with the help
of engineering person. If any failure in stability chamber happened on Holiday or during off duty
hours, Security person shall intimate to Engineering deptt. and stability In-charge. Engineering
person shall rectify the problem with the help of stability In-charge.
6.28 Alarm system of stability chamber shall be handled as respective per SOP.
6.29 In case the failure of stability chamber prolonged to more than 24 hours, initiate a deviation
as per Annexure No. QAGN005/A01. If required, samples from respective stability chamber
shall be removed and stored at room temperature and Record shall be maintained as per
Annexure No. – XIV.
6.30 Stability chamber failure investigation report shall be prepared as per Annexure No –
XVIII. with the help of engineering and Quality Assurance.
6.31 After completion of rectification of chamber, samples shall be charged again in the
respective original stability storage condition and rescheduling of the charging and withdrawal
station shall be done by adding number of days for which sample stored at room temperature to
the existing due dates for withdrawal of samples and close the deviation.
6.32 Temperature / RH Monitoring of Stability Chambers:
6.32.1 Temperature / RH of stability chamber shall be recorded by stability chemist or above on

manually basis on the interval of 2 hours as per Annexure No. – IX.
6.32.2 Temperature / RH shall be monitored through software on the interval of 1 hour and print
out shall be taken on daily basis by stability chemist or above. This printout shall be reviewed by
Executive stability / Nominee.
6.32.3 If any failure in Temperature / RH of Stability Chambers found, investigation shall be

done and note down in the Stability chamber failure investigation report as per Annexure No. –
XVIII and CAPA shall be generated as perrespective SOP.
5.33 Executive summary Report:
5.33.1 Product specific Executive summary report shall be prepared as per Annexure No. – XIX
at the time of requirement.
5.33.2 Executive summary report shall be assigned as ESR-X-YY-ZZ
First two characters (i.e. ESR) indicate for Executive summary report
Next character ( – ) is a separator
Next characters X is for product Code as per respective SOP.
Next two character YY is for report number which is a serial number, increases sequencelly for a
particular product.
Next character ( – ) is a separator
Next two characters ZZ is for version number of the report.
6.33.3 Each executive summary report consist of details as mentioned below:
Subject indicates subject of document i.e. ‘Executive Summary Report’ shall be mentioned in the
Same.
Department indicates name of the department preparing the Report i.e. ‘Quality Control’ shall be
mentioned.
Product name indicates the Brand name of the product for which the Executive summary report
shall be prepared.
Report number indicates the executive summary report number as mentioned in point number
6.33.2
Revision number indicates the version number of the Executive summary report. If it is prepared
for the first time then “00” shall be mentioned. For any subsequent revision, the revision number
“01” shall be mentioned.
Effective date indicates the date of effectiveness of Executive summary Report. Supersedes
indicates the previous version number. If report is prepared
Supersedes indicates the previous version number. If report is prepared first time then NA shall
be mentioned for every subsequent revision the revision number of previous report shall be
mentioned.
6.34 Prepare separate charging schedule, monthly planner and A. R. number register for exhibit
batches.
7.0 List of Annexure / Formats:
Stability sample Requisition Slip : Annexure-I
Schedule for charging and analysis of stability samples : Annexure-II
Summary of Long Term stability data : Annexure-III

Summary of Intermediate stability data : Annexure-IV
Summary of Accelerated stability data : Annexure-V
Label for samples of Accelerated Condition : Annexure-VI
Label for sample of Intermediate condition :Annexure-VII
Label for sample of Long term condition : Annexure-VIII
Temperature and RH monitoring record : Annexure-IX
Reconciliation of stability samples : Annexure-X
Stability Protocol : Annexure-XI
Monthly Planner : Annexure-XII
Stability study discontinuation statement : Annexure-XIII
Record of sample taken at room temperature during stability chamber failure : Annexure-XIV
Stability samples AR No. Register : Annexure-XV
Quantity of samples required for stability study : Annexure-XVI
Stability Product Failure Investigation Report :Annexure-XVII
Failure Report of stability chamber :Annexure-XVIII
Executive Summary Report :Annexure-XIX
8.0 References (if any).
USP, ICH (Q1A), ICDRA
9.0 Distribution
7.1 Master Copy : Documentation Cell (Quality Assurance)
7.2 Controlled Copies : Quality Assurance, Quality Control
10.0 History

– – New SOP

Annexure-I
Annexure-II
Annexure-III
Annexure-IV
Annexure-V
Annexure-IX
Annexure-X
Annexure-XI
Annexure-XII
Annexure-XIII
Annexure-XIV
Record of Sample Taken at Room Temperature During Stability Chamber Failure

Annexure-XV
Annexure-XVI
Annexure-XVII
Annexure-XVIII
Annexure-IX
Analytical Method of Medicinal Product Starting Generic Name with word “A”
Assay Method of Aceclofenac Tablet

Solvent Methanol
Standard 50 mg —-® 100 ml —-® take 2 ml —-® 50 ml (Shake 30 minutes)
Sample Same as standard. Take absorbance at 276 nm.

Assay Method of Albendazole Tablet
Dissolve powdered sample equivalent to about 100 mg of Albendazole in a 60 ml

previously neutralized glacial acetic acid using crystal violet solution as indicator.
Sample Titrate with 0.1M perchloric acid and determine the end point.Each ml of 0.1M
perchloric acid VS is equivalent to 26.53 mg of Albendazole.
% of content = V x F x 26.53 x 100 / weight of Albendazole in mg.
Assay Method of Allopurinol Tablet
Weigh and powder 20 tablets. Shake a quantity of the powder containing 100 mg of
Allopurinol with 20 ml of 0.05M sodium hydroxide for 20 minutes, add 80 ml of
0.1M hydrochloric acid, shake for 20 minutes, add sufficient 0.1M hydrochloric
Sample acid to produce 250 ml. Sonicate for 10 minutes. Filter the solution and dilute 2 ml
of the filtrate to 50 ml with 0.1M hydrochloric acid. Measure the absorbance of the
resulting solution at the maximum at 250 nm, using 0.1M hydrochloric acid in the
reference cell.
Calculation % of Allopurinol = Absorbance of Sample ´ 100 / Conc. Of spl. ´563
Assay Method of Almitrine Bismesylate Tablet
Mobile
Methanol 85% : Water 15%
Phase
Diluents Methanol
Standard 25 mg —-® 100 ml (Shake 15 minutes)
Sample 25 mg —-® 100 ml (Shake 15 minutes)
ODS2 5 µ 4.0 mm x 250 mm /220 nm /0.8 ml per minute/10 micro liter / 40°C /10
Condition
minutes (6 minutes approx.)
Assay Method of Alprazolam Tablet
Mobile
Methanol 90% : Distilled Water 10%
Phase
Diluents Mobile Phase
Sample Same as standard.
ODS2 5 µ 4.6 mm x 250 mm Analytical Column./ UV at 254 nm / 1 ml per minute /

Condition
20 micro liter / 40°C /10 minutes.
Assay Method of Aluminium Oxide Tablet
Take powder equivalent to 200 mg of aluminum oxide in a 100 ml volumetric

Test
flask. Add 7ml of Concentrated Hydrochloric acid & heat gently till gives a clear
preparation
solution. Cool. Add water to make volume 100 ml. Filter, if necessary.
Take 10 ml of the filtrate to a 250 ml conical flask. Add in the order named &
continuous stirring 20 ml of 0.05 M Na2EDTA VS & 20 ml of acetic acid –
ammonium acetate buffer TS. Then heat the solution near the boiling point for 5
minutes. Cool and add 50 ml of alcohol and 2 ml of dithizone TS. Titrate the
solution with 0.05 M ZnSO4 VS until a bright rose pink color produced. Each ml
Sample of 0.05 M Na2EDTA VS º 2.549 mg of Al2O3
% of Aluminium Oxide = ( 20 ´ F1 – Volume of 0.05 M

ZnSO4 ´ F2 ) ´2.549 ´ 100 / Amount of Al2O3 taken in 10ml solution (mg)
Where F1 & F2 are the factor of 0.05M Na2EDTA VS & 0.05M ZnSO4 VS
respectively.
Assay Method of Ambroxol Hydrochloride Solution
Dissolve 1.32 gm of Di -ammonium Hydrogen Phosphate into 1000 ml volumetric

Buffer flask & add 950 ml distilled water, adjust the pH 7.0 ± 0.05 with 9 % Phosphoric
Acid TS & make volume with distilled water up to 1000 ml
Ratio Acetonitrile : Buffer = 60: 40
Solvent Methanol
Sample Same as standard
Condition ODS2 , 10 m 4.6 x 250 mm / 400 C/ UV at 248 nm/15 minutes
Assay Method of Aminophylline Injection
To a volume containing 100 mg of Aminophylline add sufficient 0.01 M Sodium

Hydroxide to produce 250 ml . Dilute 5 ml to 250 ml with 0.01 M sodium Hydroxide and
Sample measure the absorbance of the resulting solution at the maximum at 275 nm . Calculate
the content of Theophylline taking 650 as the value of A (1%, 1cm ) at the maximum at 275
nm.
Calculation % of Aminophylline = Absorbance of Sample´100/Conc.Of spl.´ 650
Assay Method of Amitriptyline HCl – Tablet
Solvent 0.1 HCl
Same as standard. Measure the absorbance of both sample & standard solution at 239
Sample
nm using 0.1 M HCl as blank.
Assay Method of Amlodipine Besylate Tablet
Solvent Methanol
Same as standard. Measure the absorbance of both sample & standard solution at 237
Sample
nm using methanol as blank.
Assay Method of Amlodipine Besylate + Atenolol Tablet
Transfer accurately weighed about 2.72 gm of Potassium Dihydrogen phosphate

with 950 ml distilled water into 1000 ml volumetric flask & add 5 ml of
Buffer
Triethylamine & mix well. Adjust the pH 3.0 ± 0.05 with phosphoric acid &
make volume with distilled water up to 1000 ml.
Ratio Accetonitrile : Buffer º 40 : 60
Diluents Accetonitrile : Buffer º 40 : 60
50 mg Atenolol & 25 mg Amlodipine besylate —-® 50 ml —-® take 5 ml —-® 50

Standard
ml (Shake 20 minutes)
Waters Spherisorb 5mm ODS2 4.6 ´ 250mm./ UV at 274 nm & 237 nm / 11

Condition minutes.
Atenolol : 2.5 minutes and Amlodipine Besylate : 7.8 minutes (approximately).

Assay Method of Amlodipine Besylate + Atorvastatin Calcium Tablet
Transfer accurately weighed about 2.72 gm of Potassium Dihydrogen phosphate

with 950 ml distilled water into 1000 ml volumetric flask & add 5 ml of
Buffer
Triethylamine & mix well. Adjust the pH 3.0 ± 0.05 with phosphoric acid & make
volume with distilled water up to 1000 ml.
Mobile phase (A) : Buffer pH 2.5

Ratio
Mobile Phase ( B ) : Acetonitrile
Diluents Water ( 30% ) : Acetonitrile ( 70% )
Accurately weigh and transfer about 108.4 mg of working standard of Atorvastatin

Calcium equivalent to 100 mg Atorvastatin into a 50 ml volumetric flask. Add 10 ml
of Dimethyl sulphoxide &dissolve well. Further transfer about 34.5 mg of working
standard of Amlodipine Besylate equivalent to 25 mg of Amlodipine into the above
Standard
volumetric flask & add 30 ml solvent & shake for 20 minutes and dilute with solvent
up to the mark and mix well. Transfer 10 ml of this solution into 50 ml volumetric
flask & dilute with solvent up to the mark and mix well. Filter this solution with
0.45m membrane filter before injection.
Weigh and powder 20 Tablets. Take powder containing equivalent to 100 mg of

Atorvastatin & 25 mg of Amlodipine into 50 ml volumetric flask. Add 10 ml of
Dimethyl sulphoxide & shake well. add 30 ml solvent & shake for 20 minutes and
Sample dilute with solvent up to the mark and mix well. Transfer 10 ml of this solution into
50 ml volumetric flask & dilute with solvent up to the mark and mix well.Filter this
solution with whatmann filter paper. Finally filter this solution with 0.45m
membrane filter before injection.
Waters Spherisorb 5mm ODS2 4.6 ´ 250mm./ UV at 254 nm / 11 minutes.

Condition Amlodipine Besylate : 4 minutes and Atorvastatin Calcium : 18 minutes
(approximately).
Gradient Progragram :
Time(min.) Flow Rate Mobile Phase A Mobile Phase B
0.0 – 8.0 1.5 ml 40 60
8.0 –21.0 1.5 ml 50 50
21.01 – 30.0 1.5 ml 40 60

Assay Method of Amlodipine Besylate + Valsartan Tablet
1.74 gm of K2HPO4 was dissolved in1L of deionized water and pH was adjusted to
Buffer
3.6 by ortho-Phosphoric acid.
Degassed mixture of Phosphate Buffer (pH 3.6, 0.01M) : ACN : Methanol = 50% :
Ratio
40% : 10%
Diluents Methanol
Transfer an accurately weighted quantity of about 10 mg of Valsartan WS, 7 mg of

Amlodipine Besilate WS (equivalent to 5.049 of Amlodipine) into a 100 ml
volumetric flask then add 70 ml of solvent, shake for 10 minutes and sonicate for 30
Standard minutes. Dilute with solvent to volume and mix well .Filter this solution with
0.45 m membrane filter before injection. (Concentration of Valsartan 0.08 mg/ml and
Concentration of Amlodipine 0.05049 mg/ml).
1 mg Amlodipine ≡ 1.3864 mg of Amlodipine Besilate.
Weigh and transfer about 275 mg powder equivalent to 160 mg of Valsartan & 5 mg
of Amlodipine into a 100ml volumetric flask then add 70 ml of solvent, shake for 10
minutes and sonicate for 30 minutes. Dilute with solvent to volume and mix
Sample
well .Filter this solution with whatman filter paper. Filter this solution with
0.45 m membrane filter before injection. (Concentration of Valsartan 3.2 mg/ml and
Concentration of Amlodipine 0.05 mg/ml).
Waters Spherisorb 5mm ODS2 4.6 ´ 250 mm./ 40oC / UV at 240 nm / 1 ml per

Condition minute / 10 mL / 15 minutes.
7.5 minutes for Valsartan & 10.5 minutes for Amlodipine Besilate approximately.
Assay Method of Amoxicillin Trihydrate Tablet, Capsule & PFS
Dissolve 173 g of Sodium Hydroxide & 20.6 g of Sodium Acetate in sufficient

Buffer
water to produce 1000 ml.
Hydroxylamine
Dissolve 350 g of hydroxylamine hydrochloride in sufficient water to produce
Hydrochloride
1000 ml.
solution
Mix 1 volume each of Hydroxylamine solution and the Buffer solution. Check
Neutral
the pH & if necessary adjust the pH to 7.0 0.1 by adding an additional amount
Hydroxylamine
of one of the component. To 1 volume of this neutral solution add 8 volume of
solution
water & 2 volume of 95% ethanol. This solution must be freshly prepared.
Ferric Dissolve 272 g Ferric Ammonium Sulfate in a mixture of 26 ml of concentrate

Ammonium Sulfuric Acid and sufficient water to make 1000 ml. This solution may be used
Sulfate Solution for 1 week when stored in a brown bottle in room temperature.
Dissolve Amoxicillin Trihydrate WS equivalent to 31.25 mg of Amoxicillin in

Standard 2% w/v Sodium Bi-Carbonate solution and dilute to 25 ml with the same
solvent.
Take powder equivalent to 125 mg of Amoxicillin in a 100 ml volumetric flask,

add 70 ml of 2% w/v Sodium Bi-Carbonate solution and shake for about 20
Sample
minutes, then volume to 100 ml with 2% w/v Sodium Bi-Carbonate solution
mix and filter.
Take 2 ml solution from each standard and sample in two separate 25 ml

volumetric flask. Add 2 ml of water and 2.5 ml of Neutral Hydroxylamine
Solution, mix & allow to stand for 5 minutes. Add 2.5 ml Ferric ammonium
sulfate solution and mix.
Procedure
For Blank mix 2 ml of 2% w/v Sodium Bi-Carbonate solution with 2 ml water,
2.5 ml Neutral Hydroxylamine Solution and 2.5 ml Ferric Ammonium sulfate
solution.
After 3 minutes determine the absorbance of the resulting solutions at 480 nm.
Assay Method of Ascorbic Acid Tablet & Syrup
Accurately Transfer the 5.0 ml Syrup equivalent to 100.0 mg of Ascorbic Acid using by
5ml glass pipette which is previously ringed by sample syrup in a mixture of 20 ml of
distilled water & 15 ml of 1.0 M Sulphuric Acid to theConical flask & shake at least for
Sample 5 minutes to dissolve. Then add to 0.5ml Ferroin Solution as indicator and mix well.
Carry out a potentiometric titration using 0.1 M Ammonium Cerium (IV) Sulphate VS.
Each ml of 0.1 M Ammonium Cerium (IV) Sulphate VS is equivalent to 8.806 mg of

Ascorbic Acid.
Assay Method of Aspirin Tablet
To a quantity of the powder containing 0.5 g of Aspirin add 30 ml of 0.5M sodium

hydroxide VS, boil gently for 10 minutes and titrate the excess of alkali with 0.5M
hydrochloric acid VS using phenol red solution as indicator. Repeat the operation
Sample without the substance being examined. The difference between the titrations represents
the amount of sodium hydroxide required (V). Each ml of 0.5M sodium hydroxide VS is
equivalent to 45.04 mg of Aspirin.
Calculation: % of content = V x F x 45.04 x 100 / W
Assay Method of Atenolol Tablet
Transfer the powder equivalent to 50 mg of Atenolol in a 100-ml flask, add 60 ml of

methanol, heat the resulting suspension to 60° and shake for 15 minutes. Cool, dilute to
100 ml with methanol, filter and Dilute 10 ml of the filtrate to 50 ml with methanol.
Sample Measure the absorbance of the resulting solution at the maximum at 275 nm using
methanol as blank 53.7
% of content = Absorbance of Sample x 100 / Concentration of Sample x 53.7
Assay Method of Atorvastatin Tablet
Dissolved about 1.36 g of Potassium Dihydrogen Ortho Phosphate (KH 2PO4) in 900
Buffer ml purified water, mix well. Adjust pH to 3.2 ± 0.5 with phosphoric acid and make
volume with water up to 1000 ml.
Ratio Buffer pH 3.2 : Acetonitrile = 45 : 55
Solvent Methanol
Condition Waters XTerra RP 18 5 mm 4.6 ´ 250mm./ 40º C / UV at 235 nm / 10 minutes.

Assay Method of Azithromycin Tablet
34.84 g/L solution of Dipotassiums Hydrogen Phosphate (previously adjusted to pH

M. Phase
6.5 with Phosphoric acid) : Acetonitrile : Water = 10 : 35 : 55
Diluents Acetonitrile: Water = 60: 40
Standard 100 mg —-® 25 ml (Shake 20 minutes)
Condition Waters XTerra RP 18 5 mm 4.6 ´ 250mm./ 70º C / UV at 215 nm / 30 minutes.
SOP on Handling of Out of Trend (OOT)
 Objective:To lay down a procedure for handling of Out of trend for stability sample
 Scope:This procedure shall be applicable for handling of out of trend of stability sample
at quality control of pharmaceutical company name with location.
 Responsibility:QC personnel shall be responsible to follow the procedure as per SOP.
 Accountability:Department Head & QA Head shall be accountable for implementation of
this SOP.
 Abbreviations and Definitions:
 SOP : Standard Operating Procedure; a document where step by step instructions are
cited to serve as support for methods or manners of fulfilling a function or functions
reliably and consistently.
 OOT: Out of Trend
 STP: Standard Test Procedure
 ICH :International Conference on Harmonization
 Procedure:
 Criteria to consider a result as out of trend:
 Result shall be considered as OOT and an investigation shall be done to evaluate the
cause if following variations are observed:
 Assay:
 a) 5% change in assay from its initial value.
 Related substances:
 The result shall be consider as out of trend if:
 For impurities ( individual or total ) between 0.1 % to 0.2 % the increase / decrease in
reported value is ±100% or more from the reported value in previous station for
the same individual or total impurity.
 For impurities (individual or total) more than 0.2 % the increase / decrease in reported
value is ± 50 % or more from the reported value in previous station for the same
individual or total impurity.
 The following are not treated as OOT:
 a) The value obtained from any individual impurity is less than 0.1%.
 b) If all the values are below the limit of quantitation. One or two data may be above the
limit of quantitation.
 C) If there is an increasing trend of impurities.
 Dissolution:
 a) Failure to meet the acceptance criteria for dissolution for 12 units.
 Other tests:Significant change in appearance, physical attributes or and functionality test
(e.g. colour, phase separation,caking, hardness, dose delivery per actuation) may be
consider as out of trend. However some changes in physical attributes (e.g. softening of
suppositories, melting of creams, partial loss of adhesion of transdermal products) may be
expected under accelerated conditions and asappropriate for the dosage form.
 On observing OOT results analyst shall report to his / her supervisor.
 QC personnele shall investigate cause for OOT results based on investigation. An out of
trend result can be due to
 a) Assignable cause
 b) Non-Assignable cause
 Assignable cause for OOT results can be due to laboratory error.
 Laboratory errors occurs when an analyst makes a mistake in following the method
of analysis, uses incorrect working standard or wrongly calculation of data.
 To confirm an error is a laboratory error an investigation shall be carried outas
per Annexure.
 If the investigation reveals that the OOT is due to laboratory error, then the sample
shall be re-tested as per respective STP.
 Repeat analysis shall be done in duplicate each by the original analyst (say A)
and another analyst (say B) after taking the required corrective actions as applicable.
 If on repeat analysis the results obtained are as per expected trend then the original
testing results shall be invalidated and the repeat test results shall be reported.
 When a laboratory error is not identified (non assignable cause ) then a repeat testing
shall be planned in duplicate each by two different analyst (say B) and (say C). If the
repeat analysis results are within trend then the average of retest results shall be
reported.
 If repeat analysis results obtained are still out of trend then initial OOT results shall be
reported. Repeated results shall be identified as confirmatory results.
 If OOT is confirmed , further trend of data shall be compared with the OOT values.
 OOT investigation shall be completed within 30 days of its detection.
 Each OOT investigation shall have its own OOT number as per the following
procedure: OOT Number shall be as OOT-YYY-ZZ
 Where OOT stands for Out of Trend
 YYY stands for serial number and started from 001 for each calendar year.
 ZZ stands for year e.g. ‘16’ for 2016.
 A typical identification number of OOT is OOT-001-016.
 Where 001 is a serial number and 16 stands for year 2016.
 Maintain a record of the number of out of trend (OOT) in a log book as per Annexure.
 Out of trend ( OOT ) investigation Report-Annexure-I
 Out of trend ( OOT ) investigation log-Annexure-II
 Distribution:
o Controlled copies – Quality Assurance,Quality Control
 History
– 00 New SOP
Annexure-I
Out of trend ( OOT ) investigation Report
Product Name : OOT Number:
Batch. Number: Station:
Discovery Date: Condition:
STP number:
Effective Date: Analyst:
Test:
Specification: OOT Initial Result:
Equipment Used:
Intrument ID.:
Balance Id. No.:
Brief description of the event:

Preliminary Investigation:
1.0 Methodology Yes No Comments
1.1 Physical appearance of the solution cceptable
1.2 Correct Potency of In-house / Reference

standard used for calculation
1.3 Mobile phase was degassed properly before usage
1.4 Test and standard preparation as per approved test

procedure
1.5 Appropriate glassware used as indicated in

approved test procedure
1.6 Reagent used are appropriate and within shelf life
1.7 Correct wavelength used
1.8 Correct Normality / Molarity of Volumetric solution

used
1.9 Correct inhouse / Reference standard used
1.10 Inhouse / reference standard used within expiry date
1.11 Correct filter used
1.12 Granules / tablets were ground properly
1.13 Correct dissolution Apparatus / rpm used
1.14 Calculation performed correctly
1.15 Integration parameter acceptable
2.0 Column Yes No Comments
2.1 Correct column used ( e.g. pore

size ,dimension and make )
2.2 No leakage observed in column fitting

2.3 Raw data ( Particularly chromatogram peak shape
acceptable )
2.4 System suitability criteria meets
Conclusion / Recommendations:
3.0 Instrument Yes No Comments
3.1 Instrument within the calibration period
3.2 Instrument set-up according to standard

test procedure
3.3 Possibility of any leakage or air bubble in

the system
3.4 Correct system parameter were used

during analysis
3.5 Electric and tubing system are correct for the

system and column
4.0 For related substance only: Yes No Comments
4.1 Solution injected after freshly preparation
4.2 Peak of concern is an unknown impurity
4.3 Peak of concern is a degradation product
4.4 Peak of concern found is blank / Mobile phase / Placebo
4.5 Fresh blend used for sample preparation
5.0 General Yes No Comments
5.1 Same instrument available for investigation
5.2 Same vials available for investigation
5.3 Same standard and sample solutions available for

investigation
5.4 Same column available for investigation
6.0 Repeat Analysis ( Re-analysis ) Yes No Comments
6.1 Re-injection from the same vial to be done
6.2 Re-filteration from the same final dilution of the sample
6.3 Re-dilution from the same stock solution is done
6.4 Resonication / Reshake due to incomplete insolublization
Initial assessment Performed by/ Date:
Manager/ Nominee Review By/ Date:

Comments and conclusion:
a) Laboratory error ( Include explanation of error and data to be
reported):
b) No laboratory error
Remendial Action:
Remedial Action required: An explanation of the remendial action required:
Retraining was performed ( attach training document):
No Remedial action required:
Analyst Sign. / Date:
Manager Sign. / Date:
Annexure-II
Out of trend ( OOT ) investigation log
OOT Date o
OOT Number Observation Product Details Batch Number Test Analyst OOT
Date closure
Sampling, Preservation and Storage Procedure of Water Sample

1.0 Objective
To lay down a procedure for the Sampling, Preservation and Storage of water sample.
2.0 Scope
This Standard Operating Procedure is applicable for Sampling, Preservation and Storage of water
sample.
3.0 Responsibility
3.1 All Microbiologists/QC officers are responsible to follow the SOP.
3.2 Quality Control Head or his/her designee is responsible for compliance of this SOP.
4.0 Accountability
4.1 Department Head & QA Head shall be accountable for implementation of this SOP.
6.0 Procedure
6.1 Collect water sample for microbiological analysis in clean and sterilized nonreactive
borosilicate glass or polypropylene bottles.
6.2 Neutralized the chlorinated water sample adding 1% sterile sodium thiosulphate solution.
6.3 Open the sample port/tap fully and allow the water to drain for validated time to remove the
contamination in the pipe line.
6.4 While sampling do not contaminate inner surface of stopper or cap and neck of bottle. Do not
touch the edge of the sample container.
6.5 Fill the required volume and replace the cap immediately.
6.6 Collect quantity of water samples required for chemical testing in non-relative
borosilicate Glass or plastic bottles that have been cleaned and rinsed carefully and given a final
rinse with purified water.
6.7 Before sampling for chemical test rinse the bottle with same sample for at list 3 times, fill the
bottle completely without leaving any shape for air and replace the cap immediately.
6.8 Leave about 1% air space in the bottle sufficient to facilitate mixing by shaking before
examination.
6.1.1 Preservation and Storage
6.1.1.1 It is recommended that sample should be analyzed immediately and storage should be
avoided.
6.1.1.2 For microbiological testing analyze the sample within 6 hrs. of sampling.
6.1.1.3 Refrigerate (2 to 8 °C) the sample until is commenced.
6.1.1.4 Allow the sample to reach ambient temperature prior to testing.
6.1.1.5 Agitate sample for uniform distribution before testing.
NA
8.0 Distribution
8.1 Master copy – Quality Assurance
8.2 Controlled copies- Quality Assurance, Quality Control
9.0 History
– – New SOP
Preparation and Bio-Burden Monitoring of 70% IPA

1.0 Objective
To lay down a procedure for the preparation and bio-burden monitoring of 70% IPA.
2.0 Scope
This Standard Operating Procedure is applicable for preparation and bio-burden monitoring of
70% IPA.
3.0 Responsibility
3.1 All Microbiologists are responsible to follow the SOP.
4.0 Accountability
IPA : Isopropyl Alcohol
6.0 Procedure
6.1 Measure the required quantity of Isopropyl Alcohol in a clean measuring cylinder.
6.2 Use freshly collected distilled water for preparation of IPA solution.
6.3 Prepare IPA solution in proportion of 70:30, Isopropyl Alcohol: water.
6.4 Assemble the filtration assembly; insert sterilized o.45, 47 mm dia. Membrane filter.
6.5 Connect the assembly to vacuum pump.
6.6 Turn ON switch of vacuum pump.
6.7 Filter the prepare IPA solution.
6.8 Transfer the prepare IPA in the sterilized glass bottle.
6.9 Affix the label on the bottle with following information.
 Name of regent
 Strength
 Batch number
 Date of preparation
 Use before date
 Prepared by
6.10 Batch numbering procedure shall be as follows.
 XXA/YYYY.
 Where XX shall be current month
 A shall be Sequential number of preparation in current month and YYY shall stand for
the current year.
 Enter preparation activity in format.
 Prepared Isopropyl Alcohol shall be used 7 days from date of preparation.
NA
8.0 Distribution
9.0 History
– – New SOP
SOP for Behavior in Quality Control Department

1.0 Objective
To lay down a procedure for behavior in quality control department.
2.0 Scope
This SOP is applicable to all persons working in Quality Control department.
3.0 Responsibility
3.1 All Quality Control Officers are responsible to follow the SOP.
3.2 Quality Control Head or his/her designee is responsible for implementation of this SOP.
4.0 Accountability
4.1 Quality Control Head & QA Head shall be accountable for compliance of this SOP.
QA : Quality Assurance
SOPs : Standard Operating Procedure
MSDS : Material Safety Data Sheet
MOA : Method of Analysis
6.0 Procedure
6.1 Keep the working place neat and clean.
6.2 Follow general instruction laid down by department head.
6.3 Wear appropriate clothing as per SOP.
6.4 Follow safety guideline as per instruction given manufactures on container label, while
performing hazardous test / handling hazardous chemicals.
6.5 Carry out analysis as per their respective Specification.
6.6 Follow all respective SOP, M.O.A. during any analysis.
6.7 Follow MSDS of chemicals which is available in chemical analysis room, before performing
analysis hazardous chemicals / materials.
6.8 Handling the hazardous chemical and toxic chemicals very carefully as per respective SOP in
presence of QC Head.
6.9 Follow GLP and fill all related records on line while performing analysis properly in
respective annexures / records.
6.10 Before starting any analysis check the expiry of volumetric solution / chemicals / regents /
instrument calibration due date.
6.11 Always place back all regents / chemicals bottles to its proper place after use.
6.12 Do not keep used glassware on working platform, but place it properly in tray labelled as
“Glassware for washing”.
6.13 Always draw attention of Head in case finding any damaged or eligible regent / chemical
bottle label during working. Such labels are to be replaced.
6.14 Always handle sensitive equipment like Analytical balance very gently.
6.15 Take care to protect data sheet from any damaged / spillage on it during its use for
reporting.
6.16 Do not eat drink, chew, and smoke while performing the analysis.
6.17 Do not horse play and chit chat in laboratory?
6.18 Maintain discipline at all place.
NA
8.0 Distribution
8.2 Controlled copies – Quality Control
9.0 History
– – New SOP
Calibration and Handling of Glassware (Class A and Class B)

1.0 Objective
To lay down a procedure for the Calibration and Handling of Glassware (Class A and Class B)
2.0 Scope
This Standard Operating Procedure is applicable for calibration and Handling of Glassware
(Class A and Class B).
3.0 Responsibility
3.1 All Microbiologist/Quality Control officers are responsible to follow the SOP.
4.0 Accountability
°C : Degree Centigrade
SP : Specific
USP : United State Pharmacopeia
IP : India Pharmacopeia
6.0 Procedure
6.1 Class ‘A’ glass Apparatus:
6.1.1 These are used directly for analysis purpose and are received with calibration certificate
6.2 Calibration of Class `B’ Glass Apparatus:
6.2.1 On receiving class ‘B’ Apparatus, allot ID. No. as follows;
6.2.1.1 Volumetric Flask, VF-01
6.2.1.2 Transfer pipettes, TP-01
6.2.1.3 Burettes, BT-01
6.2.2 Before using Class ‘B’ apparatus, they should be calibrated as following procedure.
6.2.3 In all step during calibration of glassware the water temperature should be 25 °C.
6.2.4 Calibration procedure:
6.2.4.1 Take all volumetric flasks up to 1000 mL, transfer pipettes, Burettes for calibration.
6.2.4.2 For volumetric flask:
6.2.4.2.1 Weigh accurately a previously dried volumetric flask.
6.2.4.2.2 Make up the volumetric flask up to the mark with purified water.
6.2.4.2.3 Wipe dry the outside of the volumetric flask and then weigh.
6.2.4.2.4 Find out the weight of water by subtracting the empty weight of volumetric flask from
total weight (Empty volumetric flask weight and water weight).
6.2.4.2.5 Calculate the volume by taking correction factor 0.99602 gm (i.e. 1 mL of purified
water at 25°C = 0.99602 g) Record the observations in Calibration Format as per Annexure-I.
6.2.4.3 For pipette and Burette:
6.2.4.3.1 Weigh accurately previously dried empty beaker.
6.2.4.3.2 Fill the pipette and burette with purified water up to the mark with the help of bulb.
6.2.4.3.3 Wipe dry the outside of the transfer pipette & burette and then transfer the water in pre-
weighed beaker and weigh.
6.2.4.3.4 Find out the weight of water by subtracting the empty beaker weight from total weight
(Empty beaker weight and water weight).
6.2.4.3.5 Calculate the volume by taking correction factor 0.99602 gm (i.e. 1 mL of purified
water at 25°C = 0.99602 g). Record the observations in Calibration Format as per Annexure-I.
6.2.4.4 Perform the calibration in triplicate and Calculate and record the average of observed
volume.
6.2.4.5 Calculate the difference between Labeled Volume and average of observed volume of
glassware as per following formula
Difference in Volume = Labeled Volume – Average of Observed Volume
6.2.4.6 Ensure that the difference in volume shall be within the tolerance limits as listed in Table
I
Table- I Glassware Tolerance

Labeled
Volumetric 10 25 50 100 200 250 500 1000
Volume, mL
flask
Tolerance, ± mL 0.04 0.06 0.10 0.16 0.20 0.24 0.30 0.60
Labeled
Transfer 1 2 5 10 20 25 50 100
Volume, mL
Pipettes
Tolerance, ± mL 0.012 0.012 0.02 0.04 0.06 0.06 0.10 0.16
Labeled
1 2 5 10 20 25 50 100
Burettes Volume, mL
Tolerance, ± mL 0.012 0.012 0.02 0.04 0.06 0.06 0.10 0.16

Frequency: Initially when volumetric glassware is purchased.
Note: When the volumetric glassware do not comply with the requirement as specified above,
the volumetric glassware should return back to party.
6.3 Handling of Glassware
6.3.1 New glassware received should be checked for appropriateness. In case of any broken
glassware the same should be returned to the supplier.
6.3.2 Store the glassware in “Hot Air Oven”.
6.3.3 Issue the glassware as and when required.
6.3.4 Instruct the person using and cleaning the glassware to handle it carefully to avoid any
breakage.
6.3.5 In case of any breakage of glassware the same should be destroyed.
6.3.6 The glassware should be checked for any breakage after drying and broken glassware
should be destroyed.
6.3.7 Glassware, which requires calibration, should be calibrated at the time of issuance and
before use.
6.3.8 All volumetric glassware should be calibrated as per SOP of glassware calibration.
6.3.9 Enter the result in the record and take approval of authorized.
6.3.10 Before singing the record, authorized person should ensure that calibration is done as per
standard procedure and results obtained as well within limit.
Calibration of Glassware – Annexure-I
8.0 References (if any)
8.1 IP & USP
9.0 Distribution
10. History
Revision
Date Reason for Revision
Number
– – New SOP
Annexure-I
Calibration of Glassware
Name of Glassware: ID. No.:
Manufacturer: Labeled Volume:
Analytical Balance ID. No.: Calibration done on:
Observation I:
Weight of pre-weighed dry, empty, volumetric flask / Beaker, in gm (W1):________________ gm
Weight of volumetric flask/ Beaker and water, in gm (W2):__________________ gm
Weight of water, in gm (W3): = (W2 – W1) = ________________________ gm
Observed volume of the glassware: W2 – W1 = _________________ ml
D
Where: D = 0.99602 (Density of water at 25 °C in gm/ml)
Obsevation II:
Weight of volumetric flask/ Beaker and water, in gm (W2):__________________ gm
D

Observation III:
Weight of volumetric flask and water, in gm (W2):__________________ gm
D
Average of three observed volume = Sum of three Observation =
3
Difference in Volume = Labeled Volume – Average of Observed Volume
=
Tolerance Limit: ______________________ (refer to Table – I)
Table – I
Volumetric Average Volume, mL 10 25 50 100 200 250 500 1000

flask Tolerance, ± mL 0.04 0.06 0.10 0.16 0.20 0.24 0.30 0.60
Transfer Average Volume, mL 1 2 5 10 20 25 50 100

Pipettes Tolerance, ± mL 0.012 0.012 0.02 0.04 0.06 0.06 0.10 0.16
Average Volume, mL 1 2 5 10 20 25 50 100

Burettes
Tolerance, ± mL 0.012 0.012 0.02 0.04 0.06 0.06 0.10 0.16
Remarks: Glassware calibration complies / does not comply.
SOP on Validation of Microsoft Excel Calculations Worksheets

1.0 Objective
To lay down a procedure for validation of Microsoft Excel worksheets to be used for analytical
calculations.
2.0 Scope
This SOP is applicable for validation of Microsoft Excel worksheets to be used for analytical
calculations in QC lab.
3.0 Responsibility
3.1 QC Executive or above responsible for design and validate the worksheet for different test.
3.2 Head-Concerned department is responsible to ensure the accuracy of validation worksheet.
4.0 Accountability
IT : Information & Technology
SP : Specific
S.T.P No. : Standard Test Procedure Number
Spec. No. : Specification Number
A.R. No. : Analytical Reference Number
6.0 Procedure:
6.1 Control of Microsoft Excel Spread Sheet:
6.1.1 Each Worksheet shall be Product and Test Specific.
6.1.2 All worksheets used in the laboratory shall be validated with the help of IT department as
following and approved by QA department.
Validation of excel Spreadsheet
Work sheet No. ________ Product_________

Path____________ Test________

Sr. Observation
Test Parameter Activity Acceptance Criteria
No. (Yes/No)
Check availability of
Validated Excel Sheet to be Excel Sheet to be available
1. exclusive folder for
stored on a separated folder on a separate folder
validated excel sheet
Workbook Protection: The System allows opening of

Correct Password
excel workbook should be workbook.
operational by the
authorized personal with
2. right password. On
supplying wrong password Incorrect Password System disallows opening of
system should display workbook.
warning message of
incorrect password supplied.
3. Alteration:
Attempt to change
Changes or Modification in System disallows change in
a) formula or test in the
the protected cells protected cells
protected cells
Additional or deletion of the

Additional or deletion of System disallows additional /
any row/coloum in the
b) the any row/column in deletion of any row or
worksheet impacting on the
the worksheet. column.
operation of the formula
Difference between values Result By

Calculations verified
obtained from excel sheet calculator:
4. Calculations using calculator:
and calculator should not Result by
Calculator ID No.: differ. excel sheet:
 6.1.3 QC Executive or above shall design and validate the worksheet for different tests an
shall prepare a list heading “Validation Excel sheet index” as following:
Validated Excel Sheet Index
Sr. No. Product Test Spreadsheet No. Verified by Remarks
 6.1.4 Header and Footer of each worksheet shall be given below:
 6.1.5 Each validated spreadsheet used for calculation shall be numbered as QC-AABBB-
CC, where QC represents Quality Control, AA represents RM for raw material, FS for
finished product & Stability Product, IM for intermediate products and MS for
miscellaneous samples, BBB represents unique incremental no. and CC represents
version no. starting from 00.
 6.1.6 Master Excel spreadsheet shall be stored in a separate folder on the computer of
administrator.
 6.1.7 Executive or above shall act as administrator and only administrator shall have the
rights to create new master Excel worksheets.
 6.1.8 The master workbook/worksheet modification and deletion rights shall also be there
with the administrator only
 6.1.9 Master Excel worksheet shall be used for the purpose of calculations by the
Laboratory Analysts from the computer terminals in the laboratory.
 6.2 Worksheet Protection :

o 6.2.1 Each Excel spreadsheet shall be password protected.
o 6.2.2 The password shall be of eight characters having alphanumerical in nature
and one alphanumerical character in capital letter.
o 6.2.3 The password of each workbook shall be maintained as give below format:
Table of Password of Spreadsheet
Sr. Password to Password caps

Excel Sheet I.D. No. Password to open Verified by
No. open lock character
6.2.4 Each Excel workbook shall opened as “read only” option.
6.2.5 The right click option shall be deactivated for user.
6.2.6 The Excel worksheet shall be operational in “read only” format and user shall not be able
to save any data on the sheet and user shall be authorized to take print only via “Ctrl+ P”
command.
6.2.7 Addition or deletion of the any row/column in the worksheet impacting on the operation of
the formulae shall be restricted.
6.3 Validation Procedure:
6.3.1 Availability of validated Spreadsheet.
6.3.1.1 Acceptance criteria: Excel Sheet shall be available on a separate folder.
6.3.2 Wrong password.
6.3.2.1 An attempt shall be made to open the Excel workbook using a wrong password.
6.3.2.2 Acceptance criteria: The Excel workbook shall not open with the wrong password and
the system shall display the message accordingly.
(Note – Screen print carrying the system message shall be printed and attached with spreadsheet
validation document.)
6.3.3 Alteration:
6.3.3.1 An attempt shall be made to alter the contents of the protected cells, carrying the formula
and fixed contents.
6.3..3.2 Acceptance criteria: The Excel workbook shall not allow alteration of contents in the
protected cells and the system shall display a message accordingly.
(The screen print carrying the system message shall be printed and shall be attach with validation
document)
6.3.3.3 Addition or Deletion of row/column
6.3.3.3.1 An attempt shall be made to add or delete row/column
6.3.3.3.2 Acceptance criteria: The Excel workbook shall not add or delete the row/column and
the system shall display the message accordingly.
(Note: The screen print carrying the system message shall be printed and attached with
spreadsheet validation document.)
6.3.4 Verification of calculations:
6.3.4.1 Each of the calculations shall be done by calculator as well as excel sheet and result shall
be compared.
6.3.4.2 Results shall be rounded off up to decimal point.
6.3.4.3 Each of the calculations involved in the Excel worksheet shall be verified using a
qualified calculator.
6.3.4.4 Calculations done by calculator shall be recorded.
6.3.4.5 Prior to verification of calculation, it should be ensure that the formula to be used is as

per STP and should be verified as by QC Executive/nominee.
6.3.4.6 Acceptance criteria: There shall be no difference in calculated values using the Excel
worksheet and calculator.
(Note-The Excel worksheet carrying the calculated results shall be printed and recorded
observation.)
6.4 Revalidation of Excel Sheets:
6.4.1 Excel sheets shall be revalidate after every three years.
6.4.2 Excel sheets shall also be revalidate if:
6.4.2.1 Any change in the formula
6.4.2.2 Any change in design/template of Excel Sheet
Attach Related Sheets
8.0 Distribution
Controlled copies – Quality Control Lab
9.0 Reference:
If any
10.0 History

SOP on Sampling Procedure for Purified Water
1.0 Objective
To lay down a procedure for for sampling of purified water samples for chemical analysis.
2.0 Scope
This Standard Operating Procedure is applicable for for sampling of purified water samples for
chemical analysis.
3.0 Responsibility
3.1 All Microbiologists/QC officers are responsible to follow the SOP.
4.0 Accountability
Department Head & QA Head shall be accountable for implementation of this SOP.
6.0 Procedure
 Collect the purified water separately from return loop for complete chemical analysis and
from two points of use in rotation for performing only TOC and conductivity tests.
 Initially flush approximate 1 liter of purified water from each point of use and return
loop.
 For chemical analysis, collect the purified water in 1000 ml screw cap bottle. Remove the
cap of the bottle and rinse with the same purified water prior to sampling. Fill the bottle
up to the shoulder so as to collect approximately 900 ml of purified water.
 For TOC analysis, collect the purified water in 100 ml glass stoppered flask dedicated for
it.
Remove the stopper of the flask and rinse with the sample to be collected prior
to sampling.
 Immediately stopper the flask after sampling of the purified water, to

avoid contamination of atmospheric carbon in sampled purified water.
 Bring all collected purified water samples to Q.C. laboratory for testing.
NA
8.0 Distribution

 Controlled copies- Quality Assurance, Quality Control
9.0 Reference:
If any
10.0 History
Revision
Number
– – New SOP
Sampling, Preservation and Storage of Water Sample

1.0 Objective
To lay down a procedure for the Sampling, Preservation and Storage of water sample.
2.0 Scope
This Standard Operating Procedure is applicable for Sampling, Preservation and Storage of water
sample.
3.0 Responsibility
All Microbiologists/QC officers are responsible to follow the SOP.
Quality Control Head or his/her designee is responsible for compliance of this SOP.
4.0 Accountability
6.0 Procedure
6.1 Sampling of water for Microbiological analysis
 Collect water sample for microbiological analysis in clean and sterilized nonreactive
borosilicate glass or polypropylene bottles.
 Neutralized the chlorinated water sample adding 1% sterile sodium thiosulphate solution.
 Open the sample port/tap fully and allow the water to drain for validated time to remove
the contamination in the pipe line.
 While sampling do not contaminate inner surface of stopper or cap and neck of bottle. Do
not touch the edge of the sample container.
 Fill the required volume and replace the cap immediately.
 Collect quantity of water samples required for chemical testing in non-relative
borosilicate Glass or plastic bottles that have been cleaned and rinsed carefully and given
a final rinse with purified water.
 Before sampling for chemical test rinse the bottle with same sample for at list 3 times, fill
the bottle completely without leaving any shape for air and replace the cap immediately.
 Leave about 1% air space in the bottle sufficient to facilitate mixing by shaking before
examination.
6.2 Sampling of water for Chemical analysis and Bacterial Endotoxin testing
 Sample of water for chemical analysis should be collected in a clean and dried bottle and
for Bacterial Endotoxin testing sample should be collected in depyrogenated or pyrogen
free vial covered with aluminum foil.
 Open the sample port/tap fully and allow the water to drain for validated time
(approximately 1 minute) to remove the contamination in the pipe line.
 For TOC analysis collect the sample in the separate vial/bottles.
 Do not allow the vial or water in the vial to come in the contact of water.
 Without Overflowing, fill the vial.
 Close with the cap immediately Chemical analysis sample vial and Bacterial Endotoxin
testing sample cover with aluminum after sampling.
 Close the valve.
 Fill the information on the face of bottle such as location of sampling, date of sampling
with signature.
 Collect all samples and proceed for analysis as per the SOP.
6.3 Shipment
 If a contract laboratory is utilized, samples shall be sent by express service to arrive at the
contract laboratory.
 Sample container transfer “boxes” should include provision for maintaining the sample
temperature below 25°C at any time and sample should not be frozen or cooled to a
temperature 2°C.
6.4 Preservation and Storage
 It is recommended that sample should be analyzed immediately and storage should be

avoided.
 For microbiological testing analyze the sample within 6 hrs. of sampling.
 Refrigerate (2to 8°C) the sample until is commenced.
 Allow the sample to reach ambient temperature prior to testing.
 Agitate sample for uniform distribution before testing.
NA
8.0 Distribution

 Controlled copies- Quality Assurance, Quality Control
9.0 Reference:
If any
10.0 History
Revision
Number
– – New SOP
Quality Assurance
 SOP on Receipt of Raw Materials and Packaging Materials

 Qualification of Water System
 In-Process Checks During Blister Packaging
 Quality Audit: Introduction, Types and Procedure
 Product Recall: Introduction, Classification and Recall Strategy
 In-Process control & Inspection for the Small Volume Injectable (SVPs)
 Product Recall: Introduction, Classification and Recall Strategy
 Introduction to Water for Pharmaceutical Purpose
 Corrective and Preventive Actions…Basic approach
 Site Master File (SMF)
 Process FMECA in Pharmaceutical Manufacturing
 Hold Time Study …..current approach
 SOP on Quality Risk Management
 SOP on Failure Mode and Effect Analysis and Root cause Analysis
 Environmental Control – Air Handling Air Conditioning and Refrigeration
 Pharmaceutical Interview – Frequently Asked Questions
 Introduction to Pharmaceutical Clean Room
 Validation of HVAC System
 U.S. Food & Drug Administration – Complaints : Investigation & Review – 2017
 What is Calibration, Verification and Validation in pharmaceuticals?
 “Life cycle Approach to Process Validation” – Current Regulatory perspective & It’s
Benefits
 Testing of Primary Packaging Materials
 Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose
 Concept of URS, DQ, IQ, OQ, PQ
 Sampling of Inprocess Materials and Finished Products
 Presentation on Hold Time Study (OSD)
 Presentation On SOP of SOP
 Presentation On Document and Data Control
 Change Control
 Untouched area of Data Integrity in Pharmaceutical Industry
 Online Test
 DCGI Makes LSSDC Certification Compulsory For All Pharma Manufacturing Jobs
From 2018
 TSE & BSE Risk and Regulation in Pharmaceuticals
 SOP on Alarms
 SOP on Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution
 SOP on Pest & Rodent Control
 SOP on Handling of Non-Conformances
 Protocol for Validation of Sterilization Process using Steam Sterilizer (Bung Processor)
 SOP on Electronic Data Backup Management System
 SOP for Management of Equipment
 SOP on Repackaging / Re-labeling of Finished Goods
 Review, Storage, Retrieve and Disposal of Executed Batch Documents
 Sop on Rejection and Destruction Policy of Drug Products and its Components
 Corrective and Preventive Action (CAPA)
 Difference Between Calibration and Validation
 URS (User Requirement Specification) Sterile API Facility
 SOP For House Keeping Personnel Movement in Manufacturing Facility
 SOP On Facility Designing and Qualification
 Bowl Fill Seal (BFS) Technology in pharmaceutical for sterile Preparation
 SOP on Status Labeling System and Its Control
SOP on Receipt of Raw Materials and Packaging Materials
1.0 Objective:
To lay down a procedure for receiving the raw materials and packaging materials.
2.0 Scope:
This SOP is applicable for receipt of Raw and Packing material to warehouse of pharmaceutical
formulation plant.
3.0 Responsibility:
Officer or above-warehouse is responsible for receipt of raw materials and packing materials
4.0 Accountability:
Head- warehouse shall be responsible for compliance and implementation of SOP.
 RM : Raw Material

 PM : Packaging Material
 GRN : Goods Receipt Note
 MRIN : Material Received and Inspection Note
 COA : Certificate of Analysis
 AVL : Approved Vendor List
6.0 Procedure:
6.1 Receipt of the Material
6.1.1 Upon arrival of the vehicle with material, the security personnel checks the delivery
documents and ensures that consignment is meant for pharmaceutical formulation plant.
6.1.2 After confirmation of the address, the documents related to the consignment shall be sent to
warehouse office for verification before making entries into “Security Register for Incoming
RM/PM” Annexure-I.
6.1.3 Warehouse Personnel shall collect the documents through window and check the following
in the delivery documents (delivery Challan / invoice).
 Appropriateness of company address on the delivery documents.

 The vendor is approved as per current version of Approved Manufacturer / Supplier List,
including address.
 Availability of Vendor Certificate of Analysis copy.
 Reference of Purchase Order number on the delivery documents.
 Description of the material (Material name, grade/ pharmacopeia status, quantity) in
purchase order tallies with that mentioned in delivery document.
6.1.4 In case of any discrepancies observed in the above mentioned points, shall be informed to
HOD – Warehouse, and HOD – Purchase for corrective action, and vehicle should not be
allowed to enter if applicable.
6.1.5 After ensuring the adequacy of the received documents; the warehouse personnel shall send
back the documents to security personnel to make entries in the “Security Register for Incoming
RM/PM”.
6.1.6 Security personnel shall make entries in the “Security Register for Incoming RM/PM” as
per Annexure-I, after receiving the consignment documents from warehouse.
6.1.7 After entering the required details, the security personnel shall stamp on the back side of
the Invoice / Delivery Challan with serial number as per “Security Register for Incoming
RM/PM”, and received date with signature.
 The following stamp format shall be used.
PHARMAPATHWAY
GATE ENTRY No. _____ BILL No. _____
VEHICLE No. _________ DATE _________
SIGN. OF SECURITY OFFICER
6.1.8 “Gate Entry No” mentioned in the above stamp format, shall be in the form of serial
number i.e. 1, 2, 3, and so on.
6.1.9 Allow the vehicle to enter in to the plant premises.
6.2 Pre-unloading activities
6.2.1 Upon arrival of the vehicle of material at unloading area, carry out the following activities.
 Ensure that the vehicle is covered properly to protect the material.

 Instruct the vehicle driver to stop the engine to avoid carbon spillage from silencer, till
completion of unloading and transfer of material into Material Receiving Area.
 Ensure cleanliness of vehicle.
 Warehouse personnel shall check the consignment to ensure absence of material other
than mentioned in the delivery documents, in order to avoid mix-ups.
 Ensure that the Vehicle is not carrying any pesticides or oily material and shall be free
from abnormal odor.
 Ensure the material receiving area is clean before unloading the material.
 Ensure the cleanliness of the dedicated pallets available at the receiving platform.
 Ensure the cleanliness and working condition of the Hydraulic pallet trolley and vacuum
cleaner.
 Ensure the air curtain is in working condition.
 Before starting the De-dusting operation ensure that the inside door is closed.
 Ensure the weighing balance is calibrated.
 Record the observations in the format as mentioned in Annexure-II
Note: Ensure that at a time only one consignment is unloaded.
6.3 Unloading activities
6.3.1 The material shall be unloaded from the vehicle under supervision of warehouse personnel.
6.3.2 Ensure to unload the material safely from the vehicle onto the cleaned dedicated pallets on
the receiving platform.
6.3.3 Open the door of Material Receiving Area to receive the material. Ensure that the other
door of the room is closed.
6.3.4 Transfer the loaded pallets with material into Material Receiving Area and keep them
within the demarked blue line meant for cleaning/ de-dusting of received materials.
6.3.5 The Warehouse personnel shall verify each Container, Bag, Box or Drum Identification
integrity in terms of physical appearance of the consignment against the “Consignment Check
List for Raw Material & Packaging Material” Annexure-II. The following details shall be
verified.
 Material Name (To match with COA and Label on the received pack)
 Supplier/ Manufacturer Address. (To match with Approved Vendor list)
 Batch Number (where ever applicable).
 Manufacturing date (if available on the container/ Certificate of Analysis copy.)
 Expiry date / Retest date. (As available on the container/ Certificate of Analysis copy).
 Check any storage conditions are mentioned on the container label.
Note: COAs, Manufacturing date, Expiry date, and Storage conditions may not be required for
secondary/ Tertiary Printed and unprinted packaging material.
6.3.6 Deface the supplier’s / Manufacturer’s approved label available on the container / pack by
making “X” mark by marker pen.
6.3.7 Physically verify all the unloaded containers / packs, for identification, integrity, intactness
of seal, and Quantity as per Delivery documents.
6.3.8 If it is tallied, acknowledgement for material receipt is given to the driver of the vehicle by
stamping sign on the copy of the delivery documents.
 The following stamp format shall be used.
PHARMAPATHWAYSTORES RECEIVED
P.O No. ……………………………………………
No. of packs…………… Gate Entry No………….
Total Qty……………………………………………..
REMARK…………………………………………….
………………………………………………………..
SIGN…………………. Date……………………….
SUBJECT TO PHYSICAL VERIFICATION
6.3.9 If anything found damaged or unusual, handle them as explained in section 6.9.
 In case of any shortage, damaged, broken or tampered materials (occurred due to the fault
of transporter) is received, the same nature of remarks shall be mentioned on all copies of
delivery documents and sign of the driver should be taken as a confirmation.
 Communication is given to Quality Assurance department by raising the “Material
Discrepancy Report” as per Annexure-IV, to review the impact, and to initiate further
action.
6.4 DE-DUSTING PROCEDURE
6.4.1 De-dusting of the containers / packs for API and Excipients.
 Clean the external surface of the container one by one by using the vacuum cleaner (refer
RESPECTIVE SOP).
 Rotate the container sideways and ensure the vacuum suction cleans all external surfaces,
top and bottom of containers during the de-dusting.
 Clean the container with lint free duster.
 Ensure to handle the containers carefully to avoid falling and loosing of the seal during
de-dusting.
 After de-dusting and cleaning, ensure to segregate the material as per batch / lot wise.
 Transfer the cleaned containers on to the clean pallet kept on the other side of the
Demarked blue line.
6.4.2 De-dusting of containers / packs for Excipients and Primary Packaging Material in
bags/ shippers.
 Clean the external surface of the packs one by one by using the vacuum cleaner.
 Lift the Pack and ensure the vacuum suction cleans entire external surface of the pack
during the de-dusting.
 Ensure to handle the packs carefully to avoid falling and damage to the external surface
of the pack (Integrity) during de-dusting.
 After cleaning and de-dusting, ensure to segregate the material as per batch / lot wise.
 Transfer the cleaned packs on to the clean pallet kept on the other side of the Demarked
blue line.
Note: After de-dusting the shippers of Lidding foils and forming films shall be opened and the
rolls of the foils and films with protective polythene cover shall be transferred into another
polythene cover and tied with cable tie before affixing quarantine label and transfer into
Quarantine area.
6.4.3 De-dusting of Secondary (Printed) Packaging Material shippers
blue line.
 Ensure that only one consignment is received and handled at a time to avoid mix-ups.
6.4.4 De-dusting of Un-printed Packaging Material in Bundles.
blue line.
6.5 Post de-dusting procedure
6.5.1 Ensure that out side door of Material Receiving Area is closed.
6.5.2 After Completion of de-dusting operation ensure vacuum cleaner is kept in its cover before
cleaning.
6.5.3 Ensure the Waste generated in the de-dusting area is disposed off in waste bin provided.
6.5.4 Open the inside door of Material Receiving Area and transfer the containers / packs lot /
batch wise for weighing.
6.5.5 Ensure the inside door of Material Receiving Area is closed.
NOTE: During de-dusting and cleaning operation keep both the doors of the Material Receiving
Area in closed condition.
6.6 Weighing or Quantity verification procedure
6.6.1 Transfer the containers / packs by using hydraulic pallet trolley with lot wise to the
weighing area.
6.6.2 Check for the cleanliness of the balance and ensure its routine calibration as per respective
SOP No.
6.6.3 Switch on the balance and wait till zero display comes.
6.6.4 Weigh the containers/packs received one by one, on the balance provided and ensure that
quantity received is tallying as mentioned in delivery documents.
6.6.5 Follow the below mentioned weighing table plan for verification of the received containers.
No. of container No. of container to

S. No. Type of materials Remark
received in batch be verified
Active Pharmaceutical
01 – 100 % –
Ingredients
02 Excipients 5 1 –
03 Excipients 5 to 10 2 *And so on
Forming Films and Lidding

04 – 100% –
Foils
Note: *After 10 containers, for each additional five (less than 5 also) containers received verify
one container extra.
6.6.6 Record the gross weight in “Quantity Verification Record” as per Annexure-III.
6.6.7 In case of any discrepancy in the material, prepare “Material Discrepancy report”
Annexure-IV and inform to vendor through purchase department.
6.6.8 After completion of weighing, “switch off” the balance and ensure for its cleanliness.
(Refer respective SOP).
6.6.9 After weighing the packs, shall be kept on pallets for storage as per SOP on “Labeling and
Storage of Raw and Packaging Material” (refer respective SOP.)
Note: All the API containers, Excipients containers/ packs, forming film/ lidding foil rolls shall
be verified for their gross weights. Other Primary packaging material and secondary Packaging
Material shall be verified for their quantity in numbers against the received documents.
6.7 Quarantine Procedure
6.7.1 Affix “Quarantine Label” Annexure-I, on the packs and shift them to their respective
quarantines as per SOP on “Labeling and Storage of Raw and Packaging Material”.
6.7.2 Transfer the material to respective Quarantine area and store the material as per
recommended storage conditions.
6.7.3 Ensure the cleanliness of the storage racks.

6.7.4 Stack the materials in designated storage racks.
6.7.5 The warehouse personnel shall enter the material details in “Incoming Material Register
(Raw material)” as per Annexure-V and “Incoming Material Register (Packaging material)” as
per Annexure-VI.
6.6.6 Warehouse-Personnel shall prepare the GRN (Goods Received Note) as per Annexure-VII.
6.6.7 GRN Numbers shall be given as explained below.
6.7.8 The received material quantities shall be updated in the “Material Stock Card” Annexure-
VIII. (Receipt and Issue shall be printed front and back of card respectively).
6.7.9 The Goods Received Note (GRN) for Raw Material and Packaging Material shall be in
duplicate copies.
 The white copy – for store record,

 The red copy – for QC record,
6.7.10 Send Goods Received Note (GRN) to Quality Control Department.
6.7.11 Quality Control Department shall initiate for material sampling.
6.7.12 Co-ordinate with Quality Control chemist for batch wise sampling.
6.7.13 Quality Control personnel shall do the sampling from the received material, and affix
“Sampled” labels duly filled & signed on the containers/ packs which have sampled for testing.
6.7.14 Ensure the sampled containers/packs are re-sealed properly and repacked back as per
respective SOP., and send to its respective location.
6.7.15 Quantity of sample withdrawn by Quality control personnel shall be recorded in GRN and
warehouse personnel shall transcribe the quantity into “Material Stock Card”, Annexure-VIII
after final approval of GRN from QC Head.
6.8 Approval/ Rejection
6.8.1 After analysis, Quality Control shall send back the Goods Receipt Report (GRN) to
warehouse indicating the material status (Approved or Rejected) along with the Certificate of
Analysis.
6.8.2 After Testing and Release of the materials by QC, each container with “Quarantine” label
shall be affixed with “Approved” label duly filled & Signed by Quality Control Personnel.
6.8.3 Warehouse personnel shall transfer the Approved material from “Quarantine area” to the
respective Approved material Storage areas. Transfer shall follow “Labeling and Storage of Raw
and Packaging Material”.
6.8.4 Rejected material (If any, by QC) it shall be labeled as “REJECTED” duly filled & signed
(Annexure-IV) and shall be transferred to Rejected material room.
6.8.5 The details of the rejected material shall be informed to the Purchase department for further
action.
6.8.6 Warehouse personal shall raise MRIN (Material Receipt and Inspection Note), Annexure-
IX for sending to the accounts department indicating the material receipt and acceptance status
for further commercial proceedings.
6.9 Handling of shortages/ Improper labeling (Identification)/ damaged consignment:
6.9.1 Shortages:
 If number of packs received is less than that indicated in the documents and Purchase
Order note the details of shortage on the Transporter Bill.
 Take signature from the driver.
 Inform HOD-Warehouse and HOD-Purchase by telephone/ e-mail.
 Upon approval by HOD Purchase and/ or Plant Head the material may be accepted with a
shortage note in the “Material Discrepancy report Annexure-IV.
 Further action on commercial aspects with the Vendor shall be taken up by Purchase
Department.
6.9.2 Improper labeling/ Identification:
 Any discrepancy in terms of improper labeling/ Identification of the containers/packs

against the PO and documents shall be immediately inform to HOD – Warehouse, Head-
Purchase.
 If the discrepancy is confirmed that material received shall be kept in the Rejected
material room.
 The material shall be rejected with a note in the “Material Discrepancy report”,
Annexure-IV.
 Further action on commercial aspects with the Vendor shall be taken up by Purchase
Department.
6.9.3 Damaged Goods:
 If the received material is physically in damaged condition:

 Note the details in the “Material Discrepancy report”, Annexure-IV.
 Inform to HOD–Warehouse-Purchase and Plant Head.
 If Raw material and API containers/ packs received in damaged condition:
o Minor damages like dents are acceptable for Raw material and Non-sterile API
containers/ packs.
o Minor damages are not acceptable for sterile API and the material should be
rejected.
o Transfer them to rejected material room after affixing the “INPROCESS -
REJECTED” label. As per respective Annexure.
 If printed packaging material is received in damaged condition and are not in usable
condition.
o Transfer them to rejected material room after affixing the “INPROCESS -
REJECTED” label.
o Inform the purchase department.
o Printed packaging material should not be returned to the vendor.
o These materials must be destroyed inside the plant after getting approval from
HOD-QA and Plant Head in presence of QA and Vendor representative/ vendor
concurrence.
 If un-printed packaging material received in damaged condition.
o Transfer them to rejected material room after affixing the “REJECTED” label.
o These can be sent back to the vendor.
 If primary packaging material is received in damaged condition.
o Damaged packs shall be segregated from the good packs.
o Good packs may be acceptable after QC and QA verification.
 In case of damage in the consignment of Raw Material and Packaging
Material except printed packaging material, as explained above, shall be
sent back to the manufacturer/ supplier, along with ‘Gate Pass Returnable /
Non-Returnable’ as per Annexure-X detailing the reason for return
appropriate transport system.
6.10 Handling of Material for Pilot-Bio batches, Process Optimization, Scale up and Pre-
exhibit trials:
6.10.1 In case of consignments received for Pilot-Bio batches, Process Optimization, Scale up
and Pre-exhibit trials shall follow same material receipt procedure mentioned in this SOP.
6.10.2 Vendor details, Vendor COA, and relevant documents for these materials shall be
provided by Formulation Research and Development Lab.
6.10.3 Raise GRN and obtain Quality Control consent for issuing of materials for Pilot-Bio
batches, Process Optimization, Scale-up and Pre-exhibit trials.
6.10.4 QC shall provide permission in the “Consent for use of material in Pilot-Bio batches,
Process Optimization, Scale up and Pre-exhibit trials”, Annexure-XI.
6.10.5 However in such cases, the consignment status may be decided by routine sampling and
testing by Quality control or the material may be released by Quality Control Department based
on the COA provided by Formulation Research and Development Department.
7.1 Security register for incoming (Raw Material and Packaging Material) – Annexure-
I
7.2 Consignment Check list (Raw Material & Packaging Material) – Annexure-II
7.3 Quantity Verification Record – Annexure-IIII
7.4 Material Discrepancy Report – Annexure-IV
7.5 Incoming material register (Raw Material) – Annexure-V
7.6 Incoming material register (Packaging Material) – Annexure-VI
7.7 Goods Received Note – Annexure-VII
7.8 Material Stock Card – Annexure-VIII
7.9 Raw/Packing Material receipt and inspection note – Annexure-IX
7.10 Gate pass returnable / non-returnable – Annexure-X
7.11 Consent for use of material in Pilot-Bio batches, Process Optimization,
Scale up and Pre-exhibit trials – Annexure-XI
8.0 Distribution
8.2 Controlled copies – Warehouse, Personnel and Administration, Quality Assurance and
Quality Control
9.0 History
– – New SOP
Annexure-I
Annexure-II
Consignment Check List (Raw Material & Packaging Material)
Material Name: ______________________ Date: ______________
DC / Invoice No & Date.:________________
Activity Observation Remarks
Correct / Incorrect
Document Verification1. Address of “Nectar
Lifesciences Ltd.-Unit VI” on vendor
documents
Available / Not available
2. Delivery Challan / Invoice copy
3. Purchase Order Number in Vendor
documents
4. Supplier & manufacturer Name/ address as Correct / Incorrect

per “ Approved Vendor List”

5. COA from supplier / manufacturer.
6. CENVAT Copy of Invoice & Form-26
7. Security stamp on document.
Done By:- Checked By:-
Pre-Unloading Operation at Receiving Bay1. Yes / No

Vehicle is properly covered.
Yes / No
2. Cleanliness of vehicle
Complies / Not complies
3. Vehicle is not carrying any pesticides or
oily materials
4. The vehicle shall be free from abnormal Yes / No

odor

5. Ensure the vehicle engine shall be
“stopped” till completion of unloading activity. Complies / Not complies
6. Ensure cleanliness of handling equipment

and Vacuum cleaner

Cleaned / Not cleaned

7. Air curtain is switched on.

Yes / No

Yes / No
Unloading Operation1. Unloading done on

cleaned dedicated pallets
Checked / Not Checked
2. Physical condition of the material Satisfactory / Not
3. Identification labels on the container/packs Satisfactory
as per DC/Invoice
Yes / No
4. No of Packs as per DC/Invoice
Yes / No (If yes, prepare
5. Any Discrepancy.
Material Discrepancy
Report)
De-dusting Operation1. Ensure both the doors

are closed Yes / No
2. De-dust the containers / packs with Vacuum Yes / No

cleaner.

3. Transfer the containers / packs in to
cleaned pallets. Yes / No

Post De-dusting Operation1. Vacuum
Cleaner kept back in its pack. Yes / No
2. Waste generated during de-dusting Yes / No

operation is disposed off in waste bin.
Weighing Operation1. Weighing balance is

Calibrated / Not Calibrated
calibrated
Verified / Not verified
2. Daily Verification of balance.
Yes / No (If yes prepare
3. Any Discrepancy in weight Discrepancy Report)
Stamped / Not Stamped
4. Acknowledgement given to Driver duly
stamped

Yes / No
Quarantine Operation1. Affix Quarantine
labels on containers/ packs.
2. Transfer the material to respective Transferred/ Not Transferred

Quarantine Area’s

3. Entry Taken/done in incoming register.
Yes / No
4. GRN is prepared.
Yes / No
5. Material stock card updated.
Yes / No
Sign/Date: ___________________
(HOD –Warehouse)
Annexure-III
Quantity Verification Record
Material Name: GRN No :
Supplier Name: GRN Date:
Manufacturer Name:
Invoice No. / D.C. No. & Date:
Gross Weightas per Gross Weight Physical

S.No. Batch No. Remarks
D.C/ Invoice Observed
Weighed By: Checked By:
Annexure-IV
MATERIAL DISCREPANCY REPORT
Nature of Discrepancy:
Material name:
Supplier Name :
Manufacturer Name:
D.C. No. / Invoice No. & Date:
Transporter’s Name: L.R.No:
Qty as per D.C/Invoice :
Excess / Shortage Qty: Actual Received Qty:
Damage in: Outer pack Inner pack
Details:
S. No Batch No. Pack No Mfg. Date Exp. Date QTY. Remarks
QA Inspection status: Damage-Accepted Not accepted
Return to vendor Repack

Recommended stocks to be taken: ______________________
Vehicle Driver: Name: __________ Sign/Date ____________
QA Inspected by: Name: ________ Sign/Date ______________
Reported by Warehouse: Name: _______Sign/Date : _____________
Remarks:…………………………………………………………… …………
(HOD-WH) Sign./Date
Annexure-VII
GOODS RECEIVED NOTE
G.R.N.
G.R.N. No.__________________ Item code______________
Date______________
Material______________________________________________ Qty. Received__________
Supplier’s
No. of containers________
Name________________________________________________
Manufacturer’s
Invoice No._____________
Name________________________________________________
Packaging
Batch No.__________________ Invoice Date____________
status__________
Mfg. Date_________________ Exp. / Best before / Revaluation date____________
Analysis required as per – IP / USP / BP / EP / IH Signature (Stores)
(Pls. mark √ as required)

SAMPLER’S COMMENTS
No. of cont. sampled_____________________ Sampled Qty.________________________
Sampled by____________________________ Sampled on__________________________

Sampler’s remarks_____________________________________________________________Sampled by
(Q.C.)
QC COMMENTS
Release
A.R. No._________________ Potency / Assay_________
Date_____________
L.O.D / Moisture________________________ Approved / Rejected___________________
Analyst Remarks_______________________________________________________________
Retesting due on________________________
Analysed by Approved by
Annexure-IX
Raw / packing Material receipt & inspection note
P.O.No:- Bill No:- GR No:-
Supplier:- Date:- Date:- Date:-
Transporter: M/s Vehicle No.
Quantity Received Quantity.as per

S.No Description Challan/ Rate Amount Q.A.Remarks
Accepted Rejected Totalreceived
Bill

Prepared by Inspected & Approved by Authorized by
Remarks: Red Colour for Raw Material & Yellow Colour for PM have been followed separately.
Annexure-X
Works: Address
(Gate Pass Returnable/Non Returnable)
Our C.S.T. No.: Sr. No.
Our LST: Date
_____________________________________________________________________________
Consignee: ___________________________________________________________________
_____________________________________________________________________________
Party’s C.S.T. No.________________________________________________________
Through: ___________________________________________________________________
S. No. Material Description Unit Quantity Approx. Value Remarks
Purpose: __________________________________________________________________
Tentative date of return: _____________
Prepared by Checked by Authorized by Received by
Annexure-XI
Consent for use of material in Pilot-Bio batches, Process Optimization, Scale up and Pre-
exhibit trials
Material : __________________________________________________
GRN No. : _____________ Quantity : _______________
GRN Receipt Date : _____________

Consent By : __________________(Head / Sign
Deputy – QC) Date
Quality Audit: Introduction, Types and Procedure
SOP on Quality Risk Management
1.0 Objective
To describe the procedure for management of risks, arising from different operations, activities
and discrepancies.
2.0 Scope
This Standard Operating Procedure is applicable for the preparation and implementation of all
Standard Operating Procedures to be followed at Pharmaceutical formulation plant.
3.0 Responsibility
3.1 Each Operating Manager and the Department Head shall be responsible for identification of
operations and activities that pose potential risk, reporting and investigation of discrepancies,
deviations and failures within the department and carrying out Risk assessment, control and
review.
3.2 QA-Head shall be responsible for facilitating and evaluating the adequacy of Risk assessment
and its management.
3.3 Risk Management Team shall be responsible for the overall Risk Management Program, its
review and closure.
4.0 Accountability
RMT : Risk Management Team
6.0 Procedure
6.1 RMT shall be formed comprising of at least one responsible member from each function
(Quality Assurance, Production, Engineering, Quality Control, Warehouse, and Personnel &
Administration).
6.2 The “Responsibilities of the Risk Management Team” shall be as follows:
6.2.1 Assuring the Risk Management Program continuity.
6.2.2 Providing directions to the user departments.Verifying the identified cause(s) of risks.
6.2.3 Verifying the identified cause(s) of risks.
6.2.4 Risk analysis (using various tools).
6.2.5 Endorsing the identified control measures.
6.2.6 Providing guidance on implementation of control measures and time frame,
6.2.7 Assuring Risk Management Program related communication and
6.2.8 Training and reporting to the senior management.
6.3 A Quality Risk Manager shall be assigned the responsibility of coordinating the entire Risk
Management Program with all technical functions.
6.4 The “Responsibilities of the Quality Risk Manager” shall be as follows:
6.4.1 Coordinating the Risk Management Program between the user departments.
6.4.2 Organizing monthly meetings of the Risk Management Team,
6.4.3 Releasing minutes of meetings.
6.4.4 Risk communication
6.4.5 Facilitating the identification and categorization of risks.

6.4.6 Facilitating implementation of control measures.
6.4.7 Organizing follow-up and closure of risk implementation.
6.4.8 Organizing training related to Risk Management Program.
6.4.10 Preparing an annual report for the senior management.
6.4.11 Archival of related records and documentation.
6.5 RMT shall conduct regular quarterly meeting coordinated by Quality Risk Manager. The
meeting can be conducted with a minimum quorum of 3 members and the Quality Risk Manager.
However, the presence of the QA member is essential in all such meetings.
6.6 The Risk Management Program shall cover following areas:
6.6.1 Facilities and Equipment.
6.6.2 Production, processing and packing.
6.6.3 Quality Control Laboratories, Testing and Analysis.
6.6.4 Materials and warehousing.
6.6.5 Engineering, Maintenance and Utilities.
6.6.6 Quality Assurance and Quality Management System.
6.6.7 HR related GMPs.
6.6.8 Environment, Health and Safety.
6.6.9 Any other area, considered significant for the risk for running the business.
6.6.10 Each member of RMT shall ensure that any operation and activity that poses potential
risk, or any discrepancy, deviation or failure discovered in the department or its processes /
systems shall be reported by the operating personnel to the Senior Officer / Manager.Each
member of RMT shall initiate a “Risk Assessment Log” as per current Annexure- I.
6.7 Each member of RMT shall initiate a “Risk Assessment Log” as per current Annexure- I.
6.8 The department subject expert shall analyze the operation and activity, discrepancies,
deviations or failures and categorize the potential risk and its impact on the process or system or
operation and/or product quality, yield, purity, potency, identity, stability, safety or efficacy
within 15 days, depending on the seriousness of the risk and the area or process affected.
6.9 The “Risk Assessment Report” shall be prepared and compiled as per current Annexure- I.
6.10 All identified risks shall bear a unique Risk Reference number and shall be numbered as an
alphanumerical number consisting of 14 characters. For example, R/AC/MM/YY/NNN.
6.10.1 In the format number ‘R/AC/MM/YY/NNN’, the first character ‘R’ represent the Risk.
6.10.2 The 2nd character is a forward slash as separator that represents ‘/’.
6.10.3 The next two characters ‘AC’ denotes ‘Department Code’.
6.10.4 The 5th character is a forward slash as separator that represents ‘/’.
6.10.5 Next two 6th and 7th alphabetic characters ‘MM’ denote the month in which the review is
conducted.
6.10.6 The 8th character is again a forward slash as separator that represents ‘/’.
6.10.7 The next two 9th and 10th characters ‘YY’ denote the year say ‘17’ for 2017.
6.10.9 The last three characters i.e. 12th to 14th are serial number of the risk in that particular
area, starting with ‘001’ and continuing serially in increments of one unit, till 999 in a particular
year. The number would restart from the next calendar year.
6.11 Risk Evaluation:
6.11.1 Risk Priority Number (RPN) is calculated by using the formula:
RPN = Occurrence (O) x Severity (S) x Detectability (D)
6.11.2 The risk shall be rated according to the table below:
Category Low Risk Medium Risk High Risk

Occurrence 1 3 5
Severity 1 3 5
Detectability 1 3 5
RPN 1 27 125
RPN Range 1–5 9 – 45 75 – 125
6.11.3 As depicted above, the higher the risk priority number, higher is the risk and vice versa.
6.12 Occurrence (O)

6.12.1 Occurrence (O) refers to an assessment of the probability of the incident of a risk effect or
discrepancy or deviation or failure. A higher probability of occurrence may be possible if the
equipment or system or process is poorly designed or the operation is in manual mode instead of
automation.
6.12.2 The lower the probability of occurrence, the lower is the risk involved. The rating scale
for determining the probability of occurrence is given in the following Table:
Ranking Criteria
Remote probability of failure. One occurrence every six months to three years or one
1
occurrence in one million events.
Moderate probability of failure. One occurrence every three months or three
3
occurrences in 1000 events.
5 Very high probability / frequency of failure
6.13 Severity (S)
6.13.1 Severity (S) refers to an assessment of the seriousness of the risk effect or the discrepancy
or deviation or failure as it affects the end-user.
6.13.2 A higher severity rating may be assigned to process steps that involved manual operations
or interventions as compared to done by automation. The higher rating is necessary because of
quality failure or introduction of contamination during these steps will result in a higher risk to
the product safety and end-user. The lower the severity the lower the risk involved. The rating
for determining severity is given in the following Table:
Ranking Criteria
1
3
6.14 Detection (D)
6.14.1 Detection is the ability to detect a risk or an incident of defect, discrepancy, deviation or a
failure as it affects the end-user. The ability of detection depends on the system, equipment or
operation – which, with advanced technology or automated inspection will have a higher ability
to detect the defects, discrepancies or failures. In a manual mode of inspection the ability of
detection will be poor.
6.14.2 Lower the ability to detect the defect, higher is the risk.
Ranking Criteria
Assured detection of failure. 100% automatic inspection with regular calibration
1 and preventative maintenance of the inspection instrument. An effective Statistical
Process Control (SPC) program is in place.
Detection possibility is moderate. Some SPC is used in process and the product is
3
finally inspected off-line. Fault may get detected, not sure.
5 Failure is not inspected or the failure is not detectable or difficult to detect.
6.15 The risks shall be categorized as Low, Moderate or High, depending on the product of
probability of occurrence, degree of severity and ability of detection as the Risk Priority Number
(RPN) value as mentioned in 6.11.2.
6.15.1 Low Risk: This risk has low potential and is less likely to impact directly or indirectly the
process, system, operation, product quality, yield, purity, potency, identity, stability, safety or
efficacy.
6.15.2 Moderate Risk: This risk has moderate potential and is likely to moderately impact
directly or indirectly the process, system, operation, product quality, yield, purity, potency,
identity, stability, safety or efficacy.
6.15.3 High Risk: This risk has high potential and is likely to highly impact directly or indirectly
the process, system, operation, product quality, yield, purity, potency, identity, stability, safety or
efficacy.
6.16 If the risk and impact is considered to be moderate or high, the discrepancies, deviations or
failures shall be immediately reported to the QA and the Quality Risk Manager. After initial
review and assessment, it must be reported to RMT members within 5 days.
6.17 If the risk and impact is Low, then it shall be only reported to the Quality Risk Manager
within 10 working days.
6.18 For any such identified risk (Low, Moderate, High), necessary Risk Control Measures shall
be identified and evaluated to mitigate / reduce the risk to an acceptance level.
6.19 RMT shall evaluate the risk of Moderate and High categories and examine the existing
control measures and other immediate possible control measures.
6.20 RMT shall finalize the control measures and communicate to the department representative
and the Quality Risk Manager to effect implementation within a pre-determined planned time-
frame.
6.21 The determination and finalization of “Risk Control Measures, Implementation and
Deviation Closure” shall be defined as per current Annexure- III.
6.22 RMT shall also determine deployment of resources (personnel and funds) and time-frame
for implementation of control measures.
6.23 The concerned department’s RMT member shall discuss with the department group the Risk
Control Measures and the mechanism of implementation.
6.24 The Control Measures shall be implemented within the allowed time frame to complete
satisfaction. In case, the controls are not completed within the time frame allowed, an extension
can be sought in advance from RMT by the department concerned, after providing a valid reason
for the extension.
6.25 The department RMT member along with the Quality Risk Manager shall examine the
effectiveness of implementation of control measures.
6.26 The implementation activity shall be reported to RMT as per current Annexure- III.
6.27 RMT in the next meeting shall do final evaluation of the implementation and order for
Deviation Closure as per current Annexure- III.
6.28 Risk Communication and Report:
6.28.1 RMT shall identify what communication shall be released to the employees from time to
time on matters related to Risk Management and the actions undertaken.
6.28.2 It will also initiate the points to be included in the Risk related ‘Annual Report’ for the
senior management review.
6.29 Management Review:
6.29.1 The senior management representative(s) shall review the activities related to Risk
Management Program and the actions and follow-up being done by the Risk Management Team,
periodically.
6.29.2 The Annual Report shall also be reviewed by the senior management representative(s) and
a feedback will be sent to the Risk Management Team by the Quality Risk manager for
providing necessary directions and facilitation in deploying resources and funds where
necessary.
6.30 Flow Scheme:
6.30.1 The Flow scheme for the “Quality Risk Management” is depicted as per Annexure- IV for
reference and training purpose.
 Risk Assessment Log – Annexure-I

 Risk Assessment Report – Annexure-II
 Risk Control Measures, Implementation and Deviation Closure – Annexure-III
 Quality Risk Management – Annexure-IV
8.0 Distribution

 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering,
& Human Resource Development
9.0 History

– – New SOP
SOP on Quality Risk Management
1.0 Objective
To describe the procedure for management of risks, arising from different operations, activities
and discrepancies.
2.0 Scope
Standard Operating Procedures to be followed at Pharmaceutical formulation plant.
3.0 Responsibility
3.1 Each Operating Manager and the Department Head shall be responsible for identification of
operations and activities that pose potential risk, reporting and investigation of discrepancies,
deviations and failures within the department and carrying out Risk assessment, control and
review.
3.2 QA-Head shall be responsible for facilitating and evaluating the adequacy of Risk assessment
and its management.
3.3 Risk Management Team shall be responsible for the overall Risk Management Program, its
review and closure.
4.0 Accountability


RMT : Risk Management Team
6.0 Procedure
6.1 RMT shall be formed comprising of at least one responsible member from each function
(Quality Assurance, Production, Engineering, Quality Control, Warehouse, and Personnel &
Administration).
6.2 The “Responsibilities of the Risk Management Team” shall be as follows:
6.2.1 Assuring the Risk Management Program continuity.
6.2.2 Providing directions to the user departments.Verifying the identified cause(s) of risks.
6.2.3 Verifying the identified cause(s) of risks.
6.2.4 Risk analysis (using various tools).
6.2.5 Endorsing the identified control measures.
6.2.6 Providing guidance on implementation of control measures and time frame,
6.2.7 Assuring Risk Management Program related communication and
6.2.8 Training and reporting to the senior management.
6.3 A Quality Risk Manager shall be assigned the responsibility of coordinating the entire Risk
Management Program with all technical functions.
6.4 The “Responsibilities of the Quality Risk Manager” shall be as follows:
6.4.1 Coordinating the Risk Management Program between the user departments.
6.4.2 Organizing monthly meetings of the Risk Management Team,
6.4.3 Releasing minutes of meetings.
6.4.4 Risk communication

6.4.5 Facilitating the identification and categorization of risks.
6.4.6 Facilitating implementation of control measures.
6.4.7 Organizing follow-up and closure of risk implementation.
6.4.8 Organizing training related to Risk Management Program.
6.4.10 Preparing an annual report for the senior management.
6.4.11 Archival of related records and documentation.
6.5 RMT shall conduct regular quarterly meeting coordinated by Quality Risk Manager. The
meeting can be conducted with a minimum quorum of 3 members and the Quality Risk Manager.
However, the presence of the QA member is essential in all such meetings.
6.6 The Risk Management Program shall cover following areas:
6.6.1 Facilities and Equipment.
6.6.2 Production, processing and packing.
6.6.3 Quality Control Laboratories, Testing and Analysis.
6.6.4 Materials and warehousing.
6.6.5 Engineering, Maintenance and Utilities.
6.6.6 Quality Assurance and Quality Management System.
6.6.7 HR related GMPs.
6.6.8 Environment, Health and Safety.
6.6.9 Any other area, considered significant for the risk for running the business.
6.6.10 Each member of RMT shall ensure that any operation and activity that poses potential
risk, or any discrepancy, deviation or failure discovered in the department or its processes /
systems shall be reported by the operating personnel to the Senior Officer / Manager.Each
member of RMT shall initiate a “Risk Assessment Log” as per current Annexure- I.
6.7 Each member of RMT shall initiate a “Risk Assessment Log” as per current Annexure- I.
6.8 The department subject expert shall analyze the operation and activity, discrepancies,
deviations or failures and categorize the potential risk and its impact on the process or system or
operation and/or product quality, yield, purity, potency, identity, stability, safety or efficacy
within 15 days, depending on the seriousness of the risk and the area or process affected.
6.9 The “Risk Assessment Report” shall be prepared and compiled as per current Annexure- I.
6.10 All identified risks shall bear a unique Risk Reference number and shall be numbered as an
alphanumerical number consisting of 14 characters. For example, R/AC/MM/YY/NNN.
6.10.1 In the format number ‘R/AC/MM/YY/NNN’, the first character ‘R’ represent the Risk.
6.10.2 The 2nd character is a forward slash as separator that represents ‘/’.
6.10.3 The next two characters ‘AC’ denotes ‘Department Code’.
6.10.4 The 5th character is a forward slash as separator that represents ‘/’.
6.10.5 Next two 6th and 7th alphabetic characters ‘MM’ denote the month in which the review is
conducted.
6.10.7 The next two 9th and 10th characters ‘YY’ denote the year say ‘17’ for 2017.
6.10.9 The last three characters i.e. 12th to 14th are serial number of the risk in that particular
area, starting with ‘001’ and continuing serially in increments of one unit, till 999 in a particular
year. The number would restart from the next calendar year.
6.11 Risk Evaluation:
6.11.1 Risk Priority Number (RPN) is calculated by using the formula:
RPN = Occurrence (O) x Severity (S) x Detectability (D)
6.11.2 The risk shall be rated according to the table below:
Category Low Risk Medium Risk High Risk

Occurrence 1 3 5
Severity 1 3 5
Detectability 1 3 5
RPN 1 27 125
RPN Range 1–5 9 – 45 75 – 125
6.11.3 As depicted above, the higher the risk priority number, higher is the risk and vice versa.
6.12 Occurrence (O)
6.12.1 Occurrence (O) refers to an assessment of the probability of the incident of a risk effect or
discrepancy or deviation or failure. A higher probability of occurrence may be possible if the
equipment or system or process is poorly designed or the operation is in manual mode instead of
automation.
6.12.2 The lower the probability of occurrence, the lower is the risk involved. The rating scale
for determining the probability of occurrence is given in the following Table:
Ranking Criteria
1
3
6.13 Severity (S)
6.13.1 Severity (S) refers to an assessment of the seriousness of the risk effect or the discrepancy
or deviation or failure as it affects the end-user.
6.13.2 A higher severity rating may be assigned to process steps that involved manual operations
or interventions as compared to done by automation. The higher rating is necessary because of
quality failure or introduction of contamination during these steps will result in a higher risk to
the product safety and end-user. The lower the severity the lower the risk involved. The rating
for determining severity is given in the following Table:
Ranking Criteria
1
3
6.14 Detection (D)
6.14.1 Detection is the ability to detect a risk or an incident of defect, discrepancy, deviation or a
failure as it affects the end-user. The ability of detection depends on the system, equipment or
operation – which, with advanced technology or automated inspection will have a higher ability
to detect the defects, discrepancies or failures. In a manual mode of inspection the ability of
detection will be poor.
6.14.2 Lower the ability to detect the defect, higher is the risk.
Ranking Criteria
Assured detection of failure. 100% automatic inspection with regular calibration
1 and preventative maintenance of the inspection instrument. An effective Statistical
Process Control (SPC) program is in place.
Detection possibility is moderate. Some SPC is used in process and the product is
3
finally inspected off-line. Fault may get detected, not sure.
5 Failure is not inspected or the failure is not detectable or difficult to detect.
6.15 The risks shall be categorized as Low, Moderate or High, depending on the product of
probability of occurrence, degree of severity and ability of detection as the Risk Priority Number
(RPN) value as mentioned in 6.11.2.
6.15.1 Low Risk: This risk has low potential and is less likely to impact directly or indirectly the
process, system, operation, product quality, yield, purity, potency, identity, stability, safety or
efficacy.
6.15.2 Moderate Risk: This risk has moderate potential and is likely to moderately impact
directly or indirectly the process, system, operation, product quality, yield, purity, potency,
identity, stability, safety or efficacy.
6.15.3 High Risk: This risk has high potential and is likely to highly impact directly or indirectly
the process, system, operation, product quality, yield, purity, potency, identity, stability, safety or
efficacy.
6.16 If the risk and impact is considered to be moderate or high, the discrepancies, deviations or
failures shall be immediately reported to the QA and the Quality Risk Manager. After initial
review and assessment, it must be reported to RMT members within 5 days.
6.17 If the risk and impact is Low, then it shall be only reported to the Quality Risk Manager
within 10 working days.
6.18 For any such identified risk (Low, Moderate, High), necessary Risk Control Measures shall
be identified and evaluated to mitigate / reduce the risk to an acceptance level.
6.19 RMT shall evaluate the risk of Moderate and High categories and examine the existing
control measures and other immediate possible control measures.
6.20 RMT shall finalize the control measures and communicate to the department representative
and the Quality Risk Manager to effect implementation within a pre-determined planned time-
frame.
6.21 The determination and finalization of “Risk Control Measures, Implementation and
Deviation Closure” shall be defined as per current Annexure- III.
6.22 RMT shall also determine deployment of resources (personnel and funds) and time-frame
for implementation of control measures.
6.23 The concerned department’s RMT member shall discuss with the department group the Risk
Control Measures and the mechanism of implementation.
6.24 The Control Measures shall be implemented within the allowed time frame to complete
satisfaction. In case, the controls are not completed within the time frame allowed, an extension
can be sought in advance from RMT by the department concerned, after providing a valid reason
for the extension.
6.25 The department RMT member along with the Quality Risk Manager shall examine the
effectiveness of implementation of control measures.
6.26 The implementation activity shall be reported to RMT as per current Annexure- III.
6.27 RMT in the next meeting shall do final evaluation of the implementation and order for
Deviation Closure as per current Annexure- III.
6.28 Risk Communication and Report:
6.28.1 RMT shall identify what communication shall be released to the employees from time to
time on matters related to Risk Management and the actions undertaken.
6.28.2 It will also initiate the points to be included in the Risk related ‘Annual Report’ for the
senior management review.
6.29 Management Review:
6.29.1 The senior management representative(s) shall review the activities related to Risk
Management Program and the actions and follow-up being done by the Risk Management Team,
periodically.
6.29.2 The Annual Report shall also be reviewed by the senior management representative(s) and
a feedback will be sent to the Risk Management Team by the Quality Risk manager for
providing necessary directions and facilitation in deploying resources and funds where
necessary.
6.30 Flow Scheme:
6.30.1 The Flow scheme for the “Quality Risk Management” is depicted as per Annexure- IV for
reference and training purpose.
 Risk Assessment Log – Annexure-I

 Risk Assessment Report – Annexure-II
 Risk Control Measures, Implementation and Deviation Closure – Annexure-III
 Quality Risk Management – Annexure-IV
8.0 Distribution

& Human Resource Development
9.0 History

– – New SOP
SOP on Failure Mode and Effect Analysis and Root cause Analysis
1.0 Objective
To provide a guideline for conducting “Failure Mode and effect Analysis” and “Root Cause
Analysis”.
2.0 Scope
This SOP is applicable in equipment / process and for investigating the root causes of product
complaints, OOS, deviations or problems.
3.0 Responsibility
Production, Quality Assurance, Unit Head and Corporate Quality Assurance.
4.0 Accountability
QA Head shall be accountable for implementation of this SOP.
OOS : Out of specification
BMR : Batch Manufacturing Record
BPR : Batch Packing Record

Sr. No. : Serial Number
6.0 Procedure
Failure Mode and Effect Analysis (FMEA) Vs Root cause analysis (RCA):
Sr. No. FMEA RCA

Prospective, Proactive Reactive
1
Focus : Failure prevention Focus : Failure detection
Used for changes or modification in Used for product complaints, OOS,
2
equipment, process unplanned deviation, recalls.
Analyse underlying cause on occurrence of
Choose topic for evaluation of failure
3 a failure through a series of ‘WHY’
modes prior to its implementation
questions
‘Contributory factors’ for potential failure Causes of problems are investigated what
4
modes are its implementation. went wrong?
Goal: Evaluate impact of changes and
5 Goal: Preventing recurrence of problem
decrease the ‘RPN’
6 Includes detestability in evaluation Develop ways to defect and fix a problem.
6.1 FAILURE MODE AND EFFECT ANALYSIS: In conducting FMEA, the basic steps are:
6.1.1 Identify the process to be examined.
6.1.2 Assign FMEA team members and team leader.
6.1.3 Explain the methodology to the team.
6.1.4 Prepare the flow chart or detailed process flow of the process under analysis. All steps in
the process should be included.
6.1.5 Designate which of the steps in the process constitute “Functions” and identify elements
of variation in equipment, methods, materials, control and measurement.
6.1.6 Determine which functions represent potential “Failure Modes” or points of potential
failure and record in Annexure————–.
6.1.7 Determine the worst potential “Effect” or consequences of each of the failure modes.
6.1.8 Determine the “Contributory Factors” for each failure mode. (Note use of the tem
“Contributory Factor” rather than “Cause”).
6.1.9 Identify any “Controls” in the process. Controls are components of the process which (a)
reduce the likelihood of a contributory factor or a failure mode, (b) reduce the severity of an
effect, or (c) detect the occurrence of a failure Mode or Contributory Factor before it leads to the
adverse outcome (Effect). Examples of control measures are: Standard Operating Procedures,
BMR BPR, Validation, In-process controls and alarm systems.
6.1.10 Rate the severity of each (on a scale of 1-5, 1: no effect on output, 2: minor effect, 3:
moderate effect, 4: serious effect, 5: hazardous effect). The impacts of controls that improve the
severity of an effect are reflected in this rating as well.
6.1.11 Rate the occurrence (likelihood) of each contributory factor (on a scale 1-5, 1: failure
unlikely, 2: remote failure, 3: occasional failure, 4: high failure, 5: failures certain). The impacts
of controls that reduce the likelihood of occurrence of a failure mode or contributory factor are
reflected in this rating as well.
6.1.12 Based on the control measures, rate the effectiveness of each “Detection Control” (on a
scale of 1-5, 1: Flawless detection system, 2: well detect failure, 3: might detect failure, 4: almost
certain not to detect failure, 5: lack of detection control).
6.1.13 Multiply the three ratings by one another for each ‘Contributory Factors’ according to the
Risk Priority Numbers.
Note: Pareto chart with the traditional 80% rule to determine which contributory factors should
be addressed first may be used.
6.1.14 The ‘PRN’ determines the criticality of the failure mode and helps determine whether the
risk of failure should be accepted (do nothing about the potential failure), controlled (take action
to enhance detection or reduce the risk of the potential failure) or eliminated (prevent the
potential failure).
6.1.15 Using FMEA tool:
6.1.15.1 FMEA should be used to analyze the current process and evaluate the potential impact
of change under consideration. For Example: New equipment / process, major modification.
Calculate the estimated RPN each time you consider a change to the process, evaluate the impact
of the change. If RPN is high, then priority should be given to such items and based on the
current control measures, action plan for additional measures required should be made
(Annexure————–). Priority should also give to items with high severity rate.
6.1.15.2 Examples of risk that may be identified include, but are not limited to:
 Risk to manufacturing equipment such as equipment downtime, equipment damage, cost

of replacing equipment parts and any potential for injury.
 Quality of the finished product.
 Incorrect composition.
 Raw material / Packing material errors.
6.1.15.3 Examples of mitigation strategies that may be used to modify risk levels (RPN) are:
 Modify process design such as additional data verification checks.

 Introduce external procedures such as double checking of counter possible failures.
 Increase the scope and level of testing applied during various stages of validation.
Note: Validation and in-process control requirement should be reviewed.
6.1.15.4 ‘RPN’ should be recalculated periodically, once in two years to see if the changes made
are leading to an improvement over time by comparing RPN. A reduction in the RPN value
indicates an improvement.
Note: ‘RPN’ is a measure for comparison within one process only.
6.1.15.5 Allot an FMEA number to identify a process or equipment having similar principle.
Note: FMEA is often a standard tool used in the development of new products / processes.
6.1.15.6 Annexure———————— shows the FMEA flow diagram.
6.2 ROOT CAUSE ANALYSIS: the root cause analysis is aimed at first generating possible root
causes for the problem and then narrowing focus onto the most probable cause for the problem.
In conducting root cause analysis (RCA), fish bone diagram / Ishikawa diagram should be used
as the analysis tool. Steps for constructing a fish bone diagram are:
6.2.1 Define your problem from the following sources and assign RCA team members:
INTERNAL: OOS reports, self inspection, atypical results, trend analysis, FMEA, annual
product review.
EXTERNAL: Market complaints, field service reports, quality audit reports.
Root cause analysis should involve those who are most familiar with the processes and systems
and include participation of the Department Head.
6.2.2 Draw the fishbone diagram as follows:
Write the problem on the far right side of your diagram and draw a long horizontal arrow
pointing towards it.
 From the horizontal arrow, you will be able to branch off major and minor causes of this
problem. First you must identify the most significant causes, or potential causes for the
problem. These will form the main branches from the “backbone arrow”. You may start
with a few and continue to brainstorm and define about 6-8 main categories.
 From these, you can continue to brainstorm in more details, and explore why these
factors may be problems. It is best to develop as many hypotheses as possible so that no
potential root cause is overlooked.
6.2.3 Label each “bone of the fish”. The major categories utilized are:
Methods, machines, materials, people, procedure, process, suppliers, systems, measurement,

personnel, environment, controls and monitoring.
 The team should identify each process step; identify elements of variation in equipment,
measurement, personnel, environment, materials, methods, environment, controls and
monitoring.
 The term should ask a series of “whys”, repeat this with each major cause to produce sub
causes. Continue asking “Why” and classify them on the diagram. If an idea fits on more
than one branch place it on both. Be sure that the causes have a direct, logical relationship
to the problem or effect stated at the head of the fish bone. Continue until a potential root
cause has been identified. A root cause is one that can explain the “effect” and if
removed would eliminate the problem.
 Analyse the results of the fishbone after members agree that an adequate amount of detail
has been provided under each major category.
 Look for those items that appear in more that one category. These become the “most
likely causes”.
 From those items identified as the “most likely causes” the team should reach a
consensus using the team’s best collective judgment on listing those items being “most
probable cause”.
 The team should go through all the steps to determine occurrence – Root cause (why the
problem occurred ?) and then go through the steps again to determine the detection –
Root cause (why the problem wasn’t detected?).
 Record the possible causes against each category and the possible action for the causes in
Annexure————-. Priorities the causes and identify the root cause.
 Take corrective and preventative action as per ————————-.
7.0 References:
CQA ——- : Corrective and Preventative Action (CAPA).
8.0 Safety & Precautions:
Not Applicable.
9.0 History

– – New SOP

Testing of Primary Packaging Materials
1.0 Objective
To lay down a procedure for Testing of Primary Packaging Materials.
2.0 Scope
This Standard Operating Procedure is applicable pharmaceutical formulation plant.
3.0 Responsibility
QC- officer / Executive : Shall be responsible for carrying out sampling and testing of
Packaging Material.
Head QC : Shall be responsible for compilation, review of results and Release

of Products.
Head QA : Shall be responsible for compliance of this SOP
Primary Packaging Material : Packaging Material which is directly in contact with product e.g.
laminate peel able Blister lidding, cold form Laminate, HDPE Bottle, cotton plugs, etc.
SOP : Standard Operating Procedure Quality Control
HDPE : High Density Polyethylene
GTP : General Testing Procedure
COP : Certificate of Analysis
5.0 Procedure
5.1 All Primary Packaging material shall be tested as per approved specification and test
methods.
5.2 The primary packaging materials shall be tested for microbiological limit testing as per GTP
No. P-080-T, in case of only first three consecutive consignments from the Vendor.
5.3 After every one year, the approved primary packaging material shall be retested against test
parameters mentioned on the respective specification, along with microbiological testing.
5.4 Sampling of the material to be retested shall be done as per the respective SOP titled
“Sampling Procedure for Packaging Materials”.
5.5 Stores shall be responsible to intimate QC about retesting date.
5.6 Once the Material has been identified to be retested, material shall be shifted from approved
Quarantine area to under test area and “UNDER TEST” label shall be affixed.
5.7 After sampling of the material, “SAMPLED” label shall be affixed below the “UNDER
TEST” label.
5.8 QC shall perform the analysis and as per results of analysis, QC officer shall affix
“APPROVE LABEL” or “REJECTED LABEL” over the “UNDER TEST” label of each unit
pack of primary packaging material container as per relevant SOP.
Nil.
7.0 Distributions
7.1 Master Copy Documentation Cell (Quality Assurance)
7.2 Controlled Copies Quality Assurance, Quality Control, Production and Stores
8.0 History

– – New SOP
Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose
1. 0 Objective
To lay down procedure for blinding and re-labeling of Clinical Trial samples for blinded Clinical
Studies of the drug products.
2.0 Scope
This standard operating procedure is applicable for pharmaceutical formulation plant. The
procedure is applicable for blinding and re-labeling of clinical trial samples procured or
manufactured by pharmaceutical plant.
3.0 Responsibility
3.1 QA shall prepare the protocol for carrying blinding activity in-conjunction with clinical
Research Department.
3.2 Plant Head shall facilitate the blinding activity of the CTS.
33. Clinical Research Department shall prepare randomization codes, review and support in
preparation of the protocol for blinding activity.
3.4 DP shall execute the blinding and re-labeling of CTS as per the protocol.
3.5 Head, QA shall be responsible for compliance of this SOP.
DP : Designated Person
Blinding : A procedure in which one or more parties to the trial are kept unaware
of the treatment assignment(s). Single-blinding refers to the subject(s) being unaware and
double-blinding usually refers to the subject(s), investigator(s), monitor and in some cases, data
analyst(s) being unaware of the treatment assignment(s).
Randomization : The process of assigning trial subjects to treatment or control groups using
an element of chance to determine the assignments in order to reduce bias.
IPs : Investigational Products
CRO : Contract Research Organization; CRO shall carry clinical trials for
pharmaceutical plant.
PSF : Product Specification File; File containing all product specifications,

manufacturing and analytical docs related to CTS samples including copy of filled batch records
of the IP(s) and comparator(s)
IOM : Inter Office Memo
CTS : Clinical Trial Supply/ Sample
CRD : Clinical Research Department
SOPs : Standard Operating Procedures

GCP : Good Clinical Practice
CWH : Central Warehouse
5.0 Procedure
5.1 QA in conjunction with Clinical Research Department shall prepare a protocol on carrying
out blinding activity under following heads, but not limited to:
5.1.1 Objective
5.1.2 Scope
5.1.3 Responsibility
5.1.4 Abbreviations & Definitions
5.1.5 Pre-requisites
5.1.6 Procedure on blinding of CTS
5.1.7 Documentation plan
5.2 QA shall evaluate the packaging requirements and blinded labels requirements along with
Packaging Development and Clinical Research Department.
5.2.1 Coded/ blinded labels text and other GCP requirements shall be evaluated by Regulatory
Affairs, Clinical Research, R&D and QA departments
5.2.2 R&D shall support in generating the relevant specifications, test methods & packaging
procedures for packing of Clinical Trial Samples.
5.3 CRD shall intimate QA and/ or Plant Head to plan for blinding activity to be carried out on
CTS.
5.4 Upon receipt of request from the Clinical Research Department QA shall intimate DP for
clinical trial samples blinding and re-labeling.
5.5 DP shall verify the PSF of the Clinical Trial Samples and certify the same indicating their
suitability for carrying clinical trial on these samples.
5.5.1 PSF shall be prepared by QA in conjunction with R&D, if required.
5.5.2 PSF shall be given to DP by Head-QA for the verification of its contents by DP before
initiating blinding activity on CT samples.
5.6 DP will send the requisition/IOM to QA for issuance of necessary pre-requisites.
5.7 The activity of blinding shall be undertaken by authorized and trained persons. Head-QA
along with Plant Head shall constitute a team who shall support DP in blinding and re-labeling
activity.
5.7.1 Head-QA shall plan for training of the team participating in the blinding activities.
5.7.2 If required, Head-QA to ensure the training of DP on certain SOPs applicable for
carrying/executing the blinding activity.
5.7.3 The entry to the activity area shall be restricted. The entry and exit from the activity area
shall be under discretion of DP.
5.7.4 The necessary arrangements for carrying out the blinding activity shall be thoroughly
explored towards resulting the correct and error-free blinding of all CTS.
5.7.5 The temperature records wherever required shall be maintained.
5.8 The CTS samples shall be reconciled by QA & DP and the reconciliation shall be recorded
accordingly.
5.9 All the filled records shall be handed over by DP to QA after the successful completion of
the blinding activity. QA shall maintain all the records related to Clinical Trial Supply.
5.10 Signed and sealed copy of randomization and coding pattern for relabeling of CTS shall be
obtained from Clinical Research department by Head-QA.
5.10.1 Head-QA shall forward the sealed copy to DP for blinding as per the treatment
assignment(s)/ groups, based on the information given by CRD.
5.10.2 De-coding in event of adverse event and/ or adverse drug reaction shall be done as per the
suitable procedures laid down by CRD.
5.10.3 Randomization list will be patient specific and treatment specific. Patient IDs shall be
allotted to different treatment groups depending on the design of the study by CRD.
5.11 The CTS shall be properly packed under supervision of DP and DP shall handover CTS to
plant QA for dispatch to the trial site(s)/ CRO/ CWH along with the following necessary
documents:
5.11.1 Letter with necessary labeling including the handling/storage instructions duly signed by
Head-QA
5.11.2 Drug acknowledgement receipt. This receipt shall be asked for sending back by the
Investigator/CRO/CWH to the Head-QA.
5.11.3 The information regarding the dispatch of the CTS shall be duly filled in the CTS
accountability log by Head-QA.
5.12 All the documents and records shall be reconciled and verified before dispatching the CTS
to the trial site(s)/ CRO/ CWH/ by Head-QA.
5.13 If required, shipping verification for ensuring safe delivery of the CTS samples at trial
site(s) shall be planned by QA.
5.14 In case of Clinical Trial Supply to Regulatory markets, Qualified Person shall release the
clinical trial samples for dispatch to CRO based on the understanding from facility audit,
analytical results of the supply samples, report of handling of clinical trial supply and
compliance statement of Designated Person.
Nil
7.0 Distributions
7.2 Controlled Copies – Quality Assurance, Production, Quality Control, Stores, Materials,
Management, Clinical Research, Research and Development and Regulatory Affairs
8.0 History

– – New SOP
Sampling of Inprocess Materials and Finished Products
1.0 Objective
To lay down a procedure for Sampling of Inprocess materials and Finished products.
2.0 Scope
This standard operating procedure is applicable to pharmaceutical formulation plant for the
sampling of In process materials and finished products for QC analysis. This SOP shall also be
applicable for sampling of Control/Reserve Samples and Stability Samples.
3.0 Responsibility
3.1 Officer/Executive IPQA: Sampling of Inprocess materials and finished products, control /
reserve samples and stability samples.
3.2 Head, QA shall be responsible for implementation and compliance of the SOP.
S.S. : Stainless Steel
Inprocess Materials : The samples which are drawn during manufacturing process for
analysis as per BMR
IPQA : Inprocess Quality Assurance
5.0 Procedure
5.1 Head / In charge, Production or his/her designee shall generate the Analytical Request/
Report (Annexure-I), requesting IPQA for sampling of Inprocess material, Finished Products,
Control Samples and Stability Samples.
5.1.1 The Analytical Request/Report shall consist of Doublet of sheets first in white colour and
second in yellow colour.
5.1.2 The details of sampling shall be filled on the white sheet with carbon papers in between
sheets duplicating the information on each sheet.
5.1.3 Both sheets shall be forwarded to QC along with the sample.
5.1.4 QC shall record the results / observations on the white sheet and shall retain the yellow
sheet for its future reference.
5.1.5 The white sheet shall be sent to production which shall be attached in BMR.
5.1.6 IPQA Personnel shall record the details of product sent to QC for testing purpose in the
register maintained as per Annexure-V.
5.2 Sampling of In-process Materials
5.2.1 After receiving the Analytical Request/Report (Annexure-I) from production, IPQA person
shall ensure that BMR should be completed for all aspects up to the stage for which sampling has
to be done.
5.2.2 Ensure that all the containers/Bins shall be properly labelled with Product Name, Batch
No., Manufacturing Date, Gross Wt., Tare Wt., Net wt., Checked by and date, Container
Number/Bin Number and Total number containers and Stage of the process.
5.2.3 Sampling of granules shall be done with sampling rods having sampling port of appropriate
size and length .Sample for granules shall be taken from the center of bin for top, middle and
Bottom layer. The sample shall be pooled before sending to QC analysis.
5.2.4 IPQA personnel shall collect the quantity of samples required for analysis as per annexure-
VI, using sampling rods of appropriate size and length.
5.2.5 IPQA person shall paste “SAMPLED” label (Yellow in colour) (Annexure-II) with date
and signature on the containers selected for the sampling and reseal the containers tightly after
sampling.
5.2.6 IPQA person shall submit the sample after affixing label along with Analytical
Request/Report (Annexure-I) to QC for analysis. After approval of samples ‘APPROVED’ label
(Green in colour) (Annexure-II) with date and sign of IPQA person shall be pasted on all the
containers of the batch.
Sampling of Tablets and Capsules
5.2.7 When the total number of containers are 4 or less than 4, collect samples from each
container and pool. When the total number of containers are more than 4 collect samples atleast
from √n + 1 number of containers and pool (where n is total number of containers).
Note: 1) Ensure that samples are collected from 1st and the last container.
2) In case of coated tablets, collect samples individually from all the lots and from each
container.
5.2.8 Collect the sample in the suitable containers or equivalent to avoid any spillage of the
material.
5.2.9 Mention Lot No. / Batch No. separately on the ‘SAMPLED’ label (Annexure-II), if
required.
Sampling of Liquid Orals
5.2.10 Mix the bulk for 5 minutes.
5.2.11 Take the sample with the help of clean sampling rod for top, middle and bottom layer.
The sample shall be pooled before sending to QC for analysis.
5.2.12 The usage of sampling rod shall be recorded as per Annexure-IV.
Sampling of Gel/Ointment/Cream
5.2.13 Take one cleaned container with lid, of appropriate size / capacity.
5.2.14 Open the lid.
5.2.15 Draw the sample from all the storage containers with the help of an appropriate sampling
aid (with Suction Pump).Transfer the sample to the container and close the container with lid.
5.3 Sampling of Finished Products
5.3.1 Sampling of finished products shall be carried out online during packaging operations.
5.3.2 IPQA shall sample the quantity required for analysis as per annexure-6.
5.3.3 Select and pick the samples randomly from the packaging line over the period of packaging
operations at different intervals.
5.3.4 IPQA person shall submit the sample along with Analytical Request/Report (Annexure-I)
to QC for analysis.
5.4 Sampling of Control Samples
5.4.1 The control samples shall be taken online over the entire period during packaging
operations or randomly selected after completion of packaging operations.
5.4.2 IPQA person shall take twice the quantity of finished product sample sent for analysis as
control sample and shall mention the sampled quantity in the BMR.
Note: For export, the control sample quantity shall be the same as that of finished product sent to
QC for analysis
5.4.3 Enter the drawn quantity of finished product as control sample in ‘Control Sample
Sampling Record’ (Annexure-III).
5.4.4 IPQA personnel shall affix “Control Sample” stickers on samples (Annexure-II).
5.4.5 The control samples shall then be placed in the control sample room.
5.4.6 Control samples shall be sampled and stored in the same pack style as that of the finished
good.
5.5 Sampling of Stability Samples
5.5.1 IPQA shall withdraw the stability samples online over the entire period during packaging
operations as and when required.
5.5.2 The quantity of stability samples shall be as per the stability protocol of individual product.
5.5.3 IPQA shall forward the stability samples to the Incharge, Stability Cell – QC for initiation
of stability.
Note: – Samples of different stages of different dosage form shall be collected as per sampling
quantity data (Annexure-VI).
6.1 Analytical Request/Report : Annexure-I
6.2 Formats of Labels : Annexure-II
6.3 Control Sample Record : Annexure-III
6.4 Sampling Rod Usage Log Book : Annexure-IV
6.5 Product sampling record : Annexure-V
6.6 Sampling Quantity Data : Annexure-VI
7.0 Distribution
7.2 Controlled Copies – Production, Quality Control, Stores, Quality Assurance
8.0 History

– – New SOP

Annexure-I
Annexure-II
Annexure-III
Annexure-IV
Annexure-V
Annexure-VI
SOP on Issuance, Preparation, Storage, Usage and Disposal of Disinfectant

Solution
1.0 Objective
To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant
solution.
2.0 Scope
This SOP is applicable for issuance, preparation, storage, usage and disposal of disinfectant
solution in manufacturing area at pharmaceutical company.
3.0 Responsibility
GMP coordinator is responsible for the issuance of the disinfectant solution.
GMP coordinator shall responsible for receipt, storage, usage and disposal of disinfectant
solution.
Head of concerned departments shall be responsible for implementation of the SOP.
4.0 Accountability
4.1 Concerned Department Head & QA Head shall be accountable for the compliance of this
SOP.
IPA : Iso Propyl Alcohol
% : Percentage
V/v : Volume/Volume
W/v : Weight/Volume
W/w : Weight/Weight

ml : Milli Liter
SS : Stainless Steel
Ltr. : Litre
DM : De-mineralized
BP/IP : British Pharmacopoeia/Indian Pharmacopoeia
6.0 Procedure
6.1 Usage of Disinfectant Solution:
6.1.1 Disinfectant solution shall be used for following:
 Surface disinfection
 Hand disinfection
 Equipment sanitization
 Spray disinfection
 Dilute disinfectant solutions shall be used for cleaning in both manufacturing, packing
and warehouse area.
6.2 Issuance of Disinfectant solution
6.2.1 All disinfectant solution except IPA shall receive by GMP coordinator and shall store in
designated place.
6.2.2 IPA shall receive by warehouse.
6.2.3 Following disinfectant shall be used in premises for cleaning & sanitization:
S. Name of
Concentration Composition Application
No. disinfectant
Hands and
1. IPA 70% Isopropyl alcohol Surface
Disinfection.
2. Dettol 2.5% Chloroxyfenol I.P.4.8%w/v General
Antiseptic Cleaning and
Liquid Terpineol B.P.9.0%v/v Disinfection
AlcoholAbsolute13.1%
Contains Caramel I.P as

Colour
Diolkyl/dimethyl ammonium
General
chloride and
3. Pursue 0.8% Cleaning and
Alkyldimethylbenzyl
Disinfection
ammonium chloride-3.8%
General
Benzalkonium Chloride I.P.
4. Dazzl 4.5% Cleaning and
4% w/v and Carmosine
Disinfection
General
5. Cetrimide 2% Cetrimide Cleaning and
Disinfection
Chlorhexidine Gluconate –
General
5gm (0.3%w/v),
6. Savlon 2.5 % Cleaning and
Disinfection
Cetrimide – 15gm (3%w/v)
6.2.4 GMP coordinator shall issue disinfectant solution (except IPA) to housekeeping personnel
on daily basis through material issue slip IPA shall be issued by warehouse to GMP coordinator
through material issue slip.
6.3 Distribution of disinfectant solution
6.3.1 Intact container of disinfectant solution shall distribute to respective area.
6.3.2 Distribution record disinfectant solution shall maintain in the “Receiving and distribution
of Disinfectant Solution” (Annexure-I).
6.3.3 Consumption record of disinfectant shall maintain area wise in the “Disinfectant
Consumption and Destruction Record” (Annexure-II).
6.3.4 The disinfectant solution shall be stored in the respective places in manufacturing,
packaging and warehouse area.
6.4 Preparation of disinfectant solution shall be done as follows
6.4.1 After issuance disinfectant solution shall be prepared in respective area by housekeeping
personnel in presence of area Incharge.
6.4.2 Disinfectant solution shall prepared & rotate on daily basis.
6.4.3 70% IPA solution shall be used as hand disinfection as such as it is available.
6.4.4 Dilution of other disinfectant solution shall be prepared as follows:
6.4.4.1 A clean fiber bucket shall be used for preparation of disinfectant dilute solution.
6.4.4.2 Required quantity of DM water & disinfectant (as mentioned in point 6.2.3) shall
measure through graduated measuring cylinder and transfer to bucket.
6.4.4.3 To form a consistent solution, solution shall mix by using SS rod.
6.4.4.4 Dilution of disinfectant solution shall prepare as per requirement by using following
standard:
Volum
Name of Volume to be Volume of e of
S. Concentratio
Disinfectan Prepared Disinfectan DM
No. n
t (mL) t (mL) Water
(mL)
1. Dazzl 4.5% v/v 450 9550
2. Pursue 0.8% v/v 10000 80 9920
3. Cetrimide 2% w/w 200 800
Volum
Name of Volume to be Volume of e of
S. Concentratio
Disinfectan Prepared Disinfectan DM
No. n
t (mL) t (mL) Water
(mL)
Dettol
4. Antiseptic 2.5 % v/v 250 9750
10000
Liquid
5. Savlon 2.5 % v/v 250 9750
6.4.4.5 Disinfectant preparation record shall maintain as per “Receiving and distribution of
Disinfectant Solution” (Annexure-I).
6.4.4.6 Distribution record of IPA shall maintain on same Annexure I.
6.5 Disposal of Dilute Disinfectant Solution
6.5.1 After completion of the sanitization activity, discard the left over disinfectant solution by
pouring the solution into nearest drain of respective area.
6.5.2 Record the consumption and destruction of disinfectant solution in the “Disinfectant
6.6 Precautions
6.6.1 Protective wear is must while preparing the disinfectant solution.

6.6.2 Avoid spillage of disinfectant solution on the floor while preparation.
6.6.3 Do not use expired solution for cleaning.
 Receiving and Distribution of Disinfectant Solution – Annexure-I

 Disinfectant Consumption and Destruction Record – Annexure-II
8.0 Reference:
If any
9.0 Distribution

and Human Resources.
10.0 History

– – New SOP
Annexure-I
Name of Disinfectant_________________________ Use before

Date_____________________
Receive Receive
Quant Na Balan
Date of d by Issu d By
ity Distribu me ce Rema
Receivi ed
Receiv ted by of Quant rks
ng (Sign/ Qty. (Sign/
ed Area ity
Date) Date)

Annexure-II
Area Name________________ Qty. of Disinfectant Standard

Pack_______________

Name of Disinfectant____ Concentration of Disinfectant Solution__ Use before

date____________
Qty. of
Qty. Total Prepared Remaining Checked
Disinfectant
of DM Qty. Balance by Qty. by
Date of Solution
Water Prepared Quantity of Destroyed
Preparation used
Disinfectant (Sign & by (Sign & (Sign &
(Ltr.) (Ltr.) Date) Date) Date)
(Ltr.)
SOP on Alarms
1.0 Objective
The objective is to describe the procedure for electronic alarms installed on processing
Equipment, laboratory equipment and instruments.
2.0 Scope
The scope covers the Electronic Alarms for Reporting, recording, investigating, Corrective
Action and Preventive Action as applicable and required. The procedure covers only such alarms
that are installed on equipment/instruments that have a direct impact on GMPs, Products,
Processes, testing and analysis and quality or stability of the product.
3.0 Responsibility
Operating Manager
Engineering Manager
Quality Assurance
4.0 Accountability
Head-Engineering shall be accountable for compliance of SOP.
No. : Number

6.0 Procedure
6.1 This procedure is applicable to alarms generated by electronic or computerized

systems/instruments used in GMP related activities, such as.
6.1.1 Lab equipment (autoclave, HPLC, Ovens, spectrophotometers, stability chambers, lab
incubators);
6.1.2 Production equipment (vial washing equipment, tunnel sterilizer, steam sterilizer, strip
packing machine, tablet compression machines),
6.1.3 Equipment systems (pure steam generator, WFI/Purified water system, AHU systems,
Power Generator set)
6.1.4 BMS system and other equipment systems.
6.2 List of Alarm
6.2.1 Engineering department shall prepare a consolidated list (department-wise) of available

alarms on various equipment / instruments.
6.2.2 The list shall be created with the help of the department responsible person and Quality
Assurance.
6.2.3 The list will include details, such as department, S. No., Alarm type, Alarm ID, Equipment
name & ID, Location of Equipment, Functionality / Purpose.
6.2.4 The original list will be with QA in Archives and reference copy will be with Engineering
and the concerned department.
6.2.5 All operating personnel who use the equipment / instruments shall be trained on the SOP,
type & purpose / functionality of alarms, reporting procedure, logging, investigation and CAPA
actions by the QA and subject matter experts
6.3 Alarm generation and reporting
6.3.1 Alarms are generated by equipment or system when any operating parameter/condition
(input or output) exceeds the pre-set range.
6.3.2 Alarms can be sound type (beep, whistle or siren type) or display type (flashing light/
indicator).
6.3.3 When such alarms are generated, the operator/supervisor should look for source of alarm
and its cause.
6.3.4 The alarm should be promptly stopped from display and immediate corrective action shall
be taken by the operator/supervisor.
6.3.15 Such alarms shall be reported (reporting of alarms) in a Log book entitled “Reporting of
Alarms”. Refer respective Annexure for details of the log book, which will have following
details.
 Department, equipment name & ID, alarm name & ID.

 Date reported, time reported, operation affected impact on operation, category, corrective
action required, corrective action done, preventive action required, and preventive action
done.
6.3.6 Where required, help shall be taken by the operating department personnel from
engineering department or subject matter experts.
6.3.7 The alarm shall be reported by operating department and reviewed by operating manager.
In case the alarm is because of a minor cause (assign MINOR category) with no impact on
operation or product, then no investigation may be required.
However, it will be reported and necessary corrective action, if required, will be done.
6.3.8 In case the alarm is because of a major cause (assign MAJOR category), that may have
some direct or indirect impact on operation, processing, or on product, then investigation will be
required.
It will also have corrective action and preventive action, as per SOP on CAPA system.
6.4 Investigation:-
6.4.1 In case of alarm that has an impact; investigation shall be conducted by the Operating
manager, QA, Engineering and where required subject matter expert.
The investigation shall be conducted to identifying the Root cause using SQC tools, such as:
 Brainstorming,
 Process Flow Chart,
 Cause and Effect analysis or FMEA,
6.4.2 The Investigation shall be performed by the Operating Manager, QA Manager and
Engineering Manager. Where required, a subject matter expert can also be consulted.
The Investigation shall be as per the Format.
6.4.3 Based on the Root cause identification, necessary Corrective Action(s) and Preventive
Action(s) shall be identified and recommended as per SOP on CAPA system.
6.4.4 The investigation report shall be finalized by the investigation team and signed-off. It shall
be preserved in QA
6.5 CAPA
6.5.1 The Corrective Action(s) and Preventive Action(s) shall be identified by the Investigation
team based on the outcome of investigation.
6.5.2 The Corrective Action(s) shall be promptly undertaken by the concerned operating
manager with the help of engineering personnel, if required.
6.5.3 Where required Preventive Action(s) shall also be undertaken by the concerned operating
manager with the help on engineering and QA personnel, if required.
6.5.4 These CAPA actions undertaken shall be entered in the Log sheet as per SOP on CAPA
system.
6.5.5 The CAPA actions shall be closed after proper review/checks by operating personnel,
Engineering and QA personnel.
6.6 Communication
6.6.1 Necessary information/instructions shall be communicated to all concerned by the

operating manager about MAJOR alarms after the:
 Alarm was detected,

 Corrective Action(s) were identified and executed,
 Preventive Action(s) were identified and executed,
 Closure of CAPA
6.7.1 This communication shall be through a Note as per respective Annexure.
6.7 Challenging Alarms
6.7.1 The alarms for all critical operations shall be challenged at least once a year to check for
their functionality status if there was no alarm reported during the period
6.7.2 This will verify that the alarm is still functional.
6.7.3 Record for challenging of alarms shall be maintained by the Operating Department.
6.7.4 This challenge can be done by the operating manager with the help of engineering
personnel, if required.
6.7.5 Such challenge verification of critical alarms shall be logged in format log sheet
“Challenge of Alarms”, with following details:
Department, Alarm Name, Alarm ID, Equipment Name & ID, Date, Challenge test, Done by,
Checked by, Results
6.8 Alarm Trending
6.8.1 The operating manager of each department shall do a review and trending of alarms at least
once a year (calendar year) in January or February of subsequent year.
6.8.2 This shall include number of times each alarm was displayed and reported.
6.8.3 Based on the trending, the operating manager, engineering and QA can decide whether it
has any real use, or the operating range needs revision.
6.8.4 The alarm trending shall be recorded as per Log book format. This will have details such as
Department name, Alarm ID, Engineering and Equipment ID, No. of times displayed, Impact for
recommendation.
6.9 One log sheet shall be used for each alarm.
Not Applicable
8.0 Reference:
SOP on SOP
9.0 Distribution

 Controlled copies- Engineering, P&A, Production (Oral & Injectable), Warehouse,
Quality Control & Quality Assurance
10.0 History

– – New SOP
SOP on Pest & Rodent Control
1.0 Objective
To lay down the procedure to control pest & rodent within the plant.
2.0 Scope
This SOP is applicable for pest & rodent control within the plant and the factory premises at
pharmaceutical company.
3.0 Responsibility
GMP Coordinator shall be responsible for monitoring the activity.
4.0 Accountability:
QA Head shall be accountable for the implementation of this SOP.
No. : Number
ID No. : Identification No.
E.g. : Example
& : And
i.e. : That is
6.0 Procedure
6.1 Pest Control
6.1.1 All pest control activities shall be performed by outside pest control agency.
6.1.2 Annual contract shall be done with outside pest control agency.
6.1.3 The pest control activity shall be performed on weekly basis.
6.1.4 Only contractor’s trained person shall be allowed for conducting the pest control activity.
6.1.5 The area and the pesticide points shall be mentioned as per Annexure-I i.e. ‘Pest Control
Records’.
6.1.6 The person, who shall be involved in pest & rodent control activity, shall be trained and
must wear proper gown, nose mask, hand gloves & shoe cover.
6.1.7 In case of any seasonal affect in environment / climatic change due to which there is
increase of insects, flies, etc., additional services shall be taken from contractor & record should
be maintained thereof.
6.1.8 Record shall be checked by GMP Coordinator.
6.1.9 Storage of pesticide shall not be permitted in manufacturing premises.
6.1.10 Only emulsifiable concentrate (EC) grade pesticides with known antidote shall be allowed
to use as per Annexure-III.
6.1.11 Reliability of pesticides shall be checked by contractor while procurement along with
material safety data sheet.
6.1.12 Issue, preparation, use and safe disposal of pesticide container shall be the responsibility
of contractor’s person, which must be done by them at their end.
6.1.13 Ensure that the area shall be free from medicament related components during and after
the pest control till it is cleaned by housekeeping and permitted by QA for operation.
6.1.14 Ensure that pest control activity shall be done as per Annexure-I and record shall be
maintained by GMP coordinator after review from QA Department.
6.1.15 Ensure the cleaning of each pest-controlled area for absence of pesticides by GMP
Coordinator.
6.2 Rodents Control
6.2.1 The “Glue pad” shall be placed inside the roda box for controlling the rodents by the
contractor’s trained personnel fortnightly and record shall maintain in Annexure-II.
6.2.2 The roda boxes shall be identified by a unique number on the basis of their location e.g.
RB01
6.2.3 Where R stands for rodent
B stands for Box
01 stands for serial number.
6.2.3 Roda boxes location & ID no. shall be as per Annexure-II.
6.2.4 In house inspection of roda boxes shall be done by housekeeping personnel twice in a week
in supervision of GMP coordinator, records of verification shall be maintain accordingly as per
Annexure-II.
6.2.5 During inspection if any rodent shall observed than housekeeping personnel shall clean the
roda boxes and place another glue trouble gum pad.
6.2.6 Rodent shall bury and records shall maintain in Annexure-II
6.3 Insects Control
6.3.1 For controlling the insects, insectocutor shall be placed at each entry point and wherever
necessary.
6.3.2 All insectocutors shall be numbered with a unique identification no. e.g. IS01, where IS
represent the insectocutor and 01 represents the sequential serial no.
6.3.3 A list of insectocutors with ID no. & location shall maintain as per Annexure-V
6.3.4 Monitoring of insectocutor shall be done twice a day and record shall be maintain
accordingly.
6.3.5 Cleaning of insectocutors shall be done daily.
6.3.6 The numbers of insect and their type (accordingly decide the insecticide or fliocides) shall
be count daily and their record shall maintain.
6.3.7 Insectocutor tray shall clean on daily basis and the killed insect shall bury and record shall
maintain accordingly as per Annexure-IV.
6.4 Safety Precautions
6.4.1 The Insecticides / Pesticides used are highly toxic and so avoid contact with skin and eyes.
6.4.2 Inhalation should be avoided during spraying.
6.4.3 Oral ingestion to be avoided.
6.4.4 In case of poisoning, call the physician immediately.
Pest control record – Annexure-I
Rodent box inspection record – Annexure-II
Chemicals to be used for pest & rodent control – Annexure-III
Insectocutor log record – Annexure-IV

List of insectocutors – Annexure-V
8.0 Reference:
If any
9.0 Distribution
Controlled copies – Quality Assurance, Production, Stores, Quality Control, Engineering
and Human Resources.
10.0 History

– – New SOP
Annexure-I
Date: ___________ Month: _______ Week:

__________
Pesticide Used: _________________________ Frequency: weekly
Done by Checked By
Department Area
(Sign and (Sign &
Date) Date)

Outer passage and Entry
Manufacturing
point

Production Entry point

Warehouse Entry point
All the corners, passages,
Engineering entry points, around the
machines and tanks.
Admin. (QA/P&A) Entry points
F.G. Store Entry Point
Canteen Entry Points
All the passages,
Security corridors ,entry , exit
points
All the corners and the
periphery of security,
Plant
admin. Production and
Engg. Block.
Note: Pesticide must be rotate from week to week.
Annexure-II
Annexure-III
S. Brand
Composition Usage
No. Name
To kill wide range
1 Viper Plus Alphacypermethrin
of house fly.
Alpha To kill wide broad
2 Cypermethrin
Guard spectrum insects
To kill wide broad
3 Gokilaht Cyphanothrin
spectrum insects
To kill wide broad
4 K-othrin Deltamethrin
spectrum insects
5 Glue Pad Gum To trap the rodent
Location: Area:
Frequency: Twice a day Month:
Insectocutor No.:
Annexure-IV
Cleaning &
Nos. of Cleaning Disposal of
Type of Disposal
Date Time Insects insects Done
Insects
found Done By by
Checked By

Annexure-IV
Location Identification Number

Main Entrance Gallery
Main Entrance Gallery
Near Lift (in Front of P.M Store)
Liquid Finish Good Out Way
SOP on Handling of Non-Conformances
1.0 Objective
To lay down a procedure for handling of non-conformances.
2.0 Scope
This Standard Operating Procedure is applicable for handling of non-conformances associated

with product (s) manufactured at pharmaceutical formulation plants.
Non-conformances observed in in-process products and Finished Products shall be handled

through this SOP.
3.0 Responsibility
All HODs/ designee of the concerned departments shall be responsible for informing the non-
conformances, if observed, in products.
Head, Quality Assurance or designee to investigate, and to decide about the disposition of non-
conforming in process products or finished products.
4.0 Accountability
HOD’s of concerned departments & QA Head shall be accountable for implementation of this
SOP.

NCR : Non-conformance Report
Non-conforming product : Any product not conforming the established specifications and/ or
not acceptable by virtue of its appearance/ physical state and/ or by virtue of other reasons
which actually are not the part of set or established standards for that material.
Technical Committee : HODs or designee from the technical departments like QC,
QA, R&D, and Production designated for investigating or giving opinion on the non-
conformances.
6.0 Procedure
6.1 If in-process product or Finished Product is non-conforming, then it shall be quarantined with
distinct ‘HOLD’ label and shifted to the designated area under the supervision QA personnel.
6.1.1 Officer/ Executive of the concerned department shall raise NCR (Annexure-I ), mentioning
description of non-conforming in process product or finished product.
6.2 NCR shall be sent to QA for further action.
6.3 In case of in-process product or finished product, Head-QA may constitute a technical
committee who shall investigate the cause(s) of in process or finished product non-conformance.
Refer Non Conformance Investigation checklist (Annexure-2), before further movement of the
NCR to different departments.
6.3.Based on the findings of the investigations and/ or comparison with the specifications and /
or validation data and / or product development report and / or sound scientific assessment and /
or stability data with the product and / or the API molecule or the working experience with the
similar kind of products or molecules, etc., by Head-QA and / or technical committee shall then
give opinion on the non-conforming in process or finished product that whether the product can
be :
 Re graded: Non-conforming product is reassigned for an alternate market or

pharmacopeial compliance.
 Use as is: A non-conformance may be minor (no significant impact on product’s form or
function) and it can be used as is.
 Rejected: Non-conforming products are rejected, when failing in critical or major test
parameters that have significant affect on the product quality.
6.4 Concerned department shall give CAPA report, if applicable.
6.5 Following completion of investigation, each NCR shall be assigned a number by officer/
executive Quality Assurance, duly signed and dated. Each Non-conformance report shall have a
nine-digit number the form NCRXXX/YY, where:
NCR – Denotes Non-Conformance Report

XXX – Serial number of the NCR
/ – “Slash”
YY – Last two digits of the year. i.e. 16 for 2016, 17 for 2017 etc. A new series of note
shall be initiated every new year. The first NCR of the year 2015 shall be numbered as
NCR001/15.
6.6 If non-conforming in-process product or finished product is rejected then the same shall be
labeled with status ‘Rejected’ and handled as per SOP titled: Disposal of Non-Recoverable In-
process materials and SOP titled: “Destruction of finished goods” respectively.
6.7 Based upon the investigation report head quality assurance or designee shall give
his disposition on authorization of destruction of non-conforming in process or finished product.
6.8 After head quality assurance or designee’s disposition, quality assurance personnel shall send
a copy of NCR to the concerned departments.
6.9 After disposition on NCRs, the same shall be reviewed on monthly basis by QA personnel
and same shall be closed after verification.
 Non-Conformance Report – Annexure-I

 Non Conformance Investigation Checklist – Annexure-II
 Non Conformance register – Annexure-III
 Flow Chart – Annexure-IV
8.0 Distribution
 Master copy – Documentation Cell (QA)

 Controlled copies – Quality Assurance, Production, Quality Control,
Finished Goods Warehouse, Raw Material Store, Packing Material Store
9.0 Reference:
If any
10.0 History
– – New SOP
Annexure-I
NCR Number:

Write ‘NA’ if not applicable; attach extra sheet if space provided below for recording is
insufficient
Non-conforming Product:
AR No.:

Stage:
Specification No.: STP No.:

Batch No.:
Mfg. Date: Exp. Date:

Description of Non-conformance:
Recorded by HOD/

Designee
(Sign/date) (Sign/date)

Investigation and finding Statements (Attach extra sheets if required):

CAPA required/ not required :……….
CAPA number (If applicable) :……………..
Signatures with date of Technical Committee Members:
Production Quality Control R&D Stores Regulatory affairs

Disposition by Quality Assurance:
Head Quality Assurance/ Designee

(Sign./date)
Re-evaluation of Non conformance required/ not required

NCR No.: Sign: Date:
Authorization for destruction of Non-Conforming In-process product or Finished Product
Remarks
Head-Quality Assurance/ Designee

(Sign./ Date)
Re-evaluation of Non conformance required/ not required

Re-evaluation of Non conformance:
Dated ………………….. by ………………………………………Department:

……………………….
Remarks:
Sign./ Date
Closure of Non Conformance:
Dated ………………….. by ………………………………………Department:

……………………….
Remarks:
Sign./ Date
Product Name : Batch No. :
Manufacturing Date : Expiry Date:

Batch Size:
Investigators :
Name
_____________________________________________________________
Department
_________________________________________________________________
Designation
__________________________________________________________________
Investigation Started on : Investigation completed on :
Suspected cause of product failure, if any:
Note: Investigation shall not restrict to this checklist, it can go beyond it.
Annexure-II
S.
Statement Observation Remarks
No.
Checking of raw material(s) used for Batch Manufacturing and records
Check the receipt documents of the materials used for

1.
manufacture of the product under investigation:
i. Check the Goods-In-Inspection report for

physical status of consignment received.
ii. Verify if the materials, especially the

active ingredient(s) have been received from approved
vendors
a. Does Store has a current list of Approved

Vendors
Has the API(S) been received from more than one

approved vendor
(especially supplier) ? If yes, compare the

consignments received w.r.t.:
-Transportation chosen (measures taken by the

transporters to prevent exposure of material to heat,
humidity, light, etc.)
iii. Check the environmental
conditions in the quarantine area during storage of
material(s)
S. No. Statement Observation Remarks
Does the Raw Materials Specification of the raw

2. materials, especially the API include parameters
like particle size, density, etc. in its specification?
Check the raw material reserve / control samples in

Quality Control for :
3. i. Proper labelling

ii. Proper Storage
Adherence to the Standard Operating Procedures

for storage and withdrawal of control samples
Verify Standard Operating Procedures for accuracy
of procedure, records maintained and operational
status of the SOPs e.g. Material receipt, Dispensing
4. and storage of materials, handling of etc.
i. As on date of investigation
ii. During period of manufacture of product

under investigation
5. Are the materials available in Stores (both Raw
Material and Packaging Material Store)
i. Stored properly (isolated from floor and

detached from the walls)
ii. Properly Labelled
iii. Stored as per recommended Storage conditions

iv. Stored in the relevant areas
v. Retested, where applicable, as per requirement

and labelled accordingly
Check the raw material currently stored and
sampled by QC for
i. Proper labelling of the sampled containers
6. ii. Proper Resealing of the sampled container

iii. Inquire the QC Chemist for procedure
followed for sampling
– Cleaning procedure of sampling aids
– Handling of material during sampling
S.
No.
iv. Check the records maintained in QC for :
– Date of receipt of sample in QC

– Conditions during storage of material in QC
– Date of release of:

Check the calculation used for dispensing of active
ingredient.
7.
a. Has the calculation been checked by production
personnel and verified by QC personnel?
8. Check the weighment sheet and issuance record for raw
materials issued for manufacture of the product in the
Store for :
i. Quantities of materials dispensed

S.
No.
ii. AR. No. of materials dispensed
iii. Conformance of issuance of materials to FEFO
COA of materials dispensed and retest date (cross check

AR. No. recorded in the issuance records, value of assay,
water/ LOD, etc.)

Check the Open Fronted Containment Facility (OFCF)
Records at the time of dispensing for the product batch:
i. Area purging records
ii. Line purging
iii. Cleaning records(of both OFCF, dispensing aids and

9. vessels/ containers in which the materials have been
dispensed
iv. Machine Log sheet
Preventive Maintenance

Check the Status of balances used for dispensing of Raw
Materials in Store for :
10.
i. Calibration Status
ii. Cleaning Status

Has any material been released on deviation? If yes,
verify:
11.
i. Reason of deviation
ii. Deviation authorised by

12. If the material is still available in stores, check the
S.
No.
following:
i. Labelling on the containers
ii. Retest date, if applicable on the label
iii. Proper storage

Check the calibration records of :
i. Balances used for dispensing

13.
ii. Hygrometer
iii. Pressure gauges of the Open Fronted Containment

Facility
iv. Master weight certificate (Issuance date:

valid up to:
Is the access to the printed packaging material store

14.
restricted?
Does Store maintain list of persons authorised to entry

15.
areas with “restricted entry”?
Checking of Manufacturing Operation and records
Verify Standard Operating Procedures relevant to

different manufacturing operations. Are these ‘current’?
16.
i. As on date of investigation
ii. During the period of manufacture of the product

17. During the period of manufacture of the product
Are the equipment labelled according to their status and

18.
content?
19. Is the manufacturing area clean?
i. Check area cleaning records

S.
No.
ii. Has the frequency of cleaning as per SOP
iii. Has rotation of disinfectants implemented
iv. Has the checking of area undertaken by QA as

per frequency mentioned in the SOP
Check and record the following information w.r.t.
product under investigation:
i. Material dispensed on:

20.
ii. Batch manufacturing started on : (date)
(time)
iii. Storage conditions of materials during the

period dispensed material was stored prior to the start of
batch manufacturing:
Observe the area environment conditions and cross
21.
check with the records.
Select any machine e.g. blender, sifter, filling machine

and check the following:
i. Line purging record (cross check with the Batch

Manufacturing Record of the previous product
22.
mentioned)
ii. Preventive maintenance label and verify
iii. Calibration records of instruments, where

applicable
iv. Qualification data

Check the Batch Manufacturing Record of the product
under investigation
23.
i. For overwriting, cutting or any other indications

suggestive of intentional change in data.
ii. Environmental conditions at the time of

manufacturing
S.
No.
iii. Check the equipment used for manufacture

of the product for:
a. Description/ capacity of equipment as per BMR
b. Line purging
c. Calibration status of critical instruments, if

applicable
d. Preventive Maintenance Status
e. Training records of the personnel who operated the

machines at the time of manufacture of the product
(Select any three machines e.g. Compression/ Capsule
filling/ Bottle filling, blender, FBD, etc.)

Machine name and code Operator Name
Operator Name Operator Name
_________________ ____________

____________ ___________
_______________ ___________
___________ __________
_______________ ____________

___________ __________
iv. Are all the production stages entries signed by

designated personnel?
v. Has the “on-line” in-process test undertaken by

production personnel as mentioned in the BMR of the
product?
vi. Has the sampling for in-process tests other than the
above mentioned, been conducted by IPQA /QC
personnel?
vii. Check the In-process testing records for:

S.
No.
a. Check if the parameters tested is an per specification

or as mentioned in BMR
b. Check if the in-process request is signed and dated

both by production and QA, as appropriate
c. Check the raw data
d. Is the analysis records signed by both person who

executes them and an authorised person from QC
e. Verify if the testing has been done as per Standard

Testing Procedure
viii. Has the thorough put time of the process

gone beyond the normal judged time?
ix. Is the Process Capability Index, if any

available for the product?

Observe the Batch Manufacturing Record for duration
for which various intermediates have been stored?
Record few examples.
Stage Process Completed on

Next step started on ______________
24. _____________________ ______________________
______________
_____________________
______________________
Does the period suggest any detrimental effect on the

quality of intermediate e.g. de-blending?
Has difference between particle size of various
25. ingredients evaluated during product development/
validation?
26. Has Purified Water been used during manufacture of

S.
No.
product? If yes, check:
i. Sampling procedures followed
ii. Testing records
iii. Release reports

Does the product intermediates like blend, compressed
tablets, etc. require specific storage conditions? If yes,
then check the following:
i. i. Storage Area environmental records for the

period when the intermediate was stored
27. ii. Period for which the intermediate was stored
iii. Is the entry to the Intermediate storage area

restricted
iv. Is list of person(s) authorised for entry into

restricted areas available

Is the packaging material stored in the designated area?
Check the storage of issued packaging materials,
especially printed packaging material, before use
28.

Check the packaging materials issued for the product
for:
29.
i. Quantities issued
ii. Stock register of stores for compliance to FIFO
iii. Verification of Quantities by production after

receipt of material in production
30. Is the entry to the Printed Packaging Material
S.
No.
Restricted?
Does Packaging Material Store Maintain a list of

31.
person(s) authorised for entry into restricted areas?
Was line and area purging done before start of printing

and packaging operations?
32.
Check the line purging records of the packaging

machine.
Verify
33.
Time of issue of Packaging Material:
Time of Start of Packaging Operation:

Has reconciliation of packaging material done after
34.
completion of batch?
Has the returned packaging material adequately entered

35.
in the Store registers?
Has destruction of packaging materials, especially

36. printed packaging material, done under the supervision
of QA personnel?
v. Check the Control Samples of the product:
i. Quantity of samples withdrawn
37. ii. Physical condition of Control Samples
iii. Condition of Control Sample storage area.
iv. Is the access to Control Sample storage area

restricted
38. Verify if the yields at different stages of manufacturing
operations of the product.
i. If within the limit, compare the yield with at least

preceding two batches and succeeding batch.
S.
No.
ii. If out of limit, has deviation been raised and

investigated?
iii. Are any corrective and preventive actions taken?

Has deviation occurred during manufacturing? If yes,
has deviation been raised?
39. i. Deviation Report No.:
ii. Has investigation been completed
iii.If investigation is pending, reason:

i. Date of transfer to Quarantine Finished Goods
Stores:
ii. Date of release of batch by Production:
iii. Date of release of batch by

40.
QA:
iv. Does the product has any

microbiological testing? If yes, date of release of batch
after microbiological analysis:
v. Date of dispatch of first consignment

and quantity:
Check the Distribution Warehouse for:
iv. Storage condition

41.
v. Environmental conditions
vi. Labelling
vii. Segregation
42. Are temperature and relative humidity records available
during the transit and transportation of the finished
products?
S.
No.
– If no, reasons thereof
– If yes, are the conditions appropriate with the

labelled storage conditions
– Collect data of a period spreading across

different season to obtain information regarding
environmental conditions during transportation.

Other Queries
What tests have been used to assess the uniformity of the

43. final product? Verify the Content Uniformity/ weight
variation testing?
Check for a possible interactions between the process

44. and its effect on the tablets compression e.g. tablet
machine rpm on the dwell time and hardness or capping
Does any ingredient in the formulation affects the

density of the final blend to a greater extent than any
45.
other ingredient? If yes, does the specification ensures
the density of such ingredient is well controlled?
Has the manufacturer informed Torque Pharmaceuticals

46. regarding any major changes, if undertaken in process or
specifications of the material being supplied by him?
Annexure-III

Non NCR closed
Batch Mfg Exp. Details of Non Implementation
NCR Deptt. Stage by date
No. date date conformance Status
No. Conformance (Sign/Date)
product

Annexure-IV
SOP on Electronic Data Backup Management System
1.0 Objective
To lay down a procedure for electronic data backup management system.
2.0 Scope
This standard operating procedure is applicable at IT department of pharmaceutical company.
3.0 Responsibility
IT personnel shall be responsible for taking the backup.
IT personnel shall be responsible for retrieving the tapes form other location.
Officer/Executive IT shall be responsible for destruction of backup tapes.
Head-QA/Designee shall be responsible for the compliance of the SOP.

functionsreliably and consistently.
IT : Information Technology
5.0 Procedure
5.1 For Whole Plant
5.1.1 Frequency: Monthly
5.1.2 Backup shall be taken by IT personnel in a new tape.
5.1.3 Tape shall be assigned with a unique eleven digit alphanumeric characters.
5.1.3.1 First Character shall be “P” denoting pharmaceutical company.
5.1.3.2 Second character shall be “B” representing Backup.

5.1.3.3 Third and fourth character shall represents code assigned to the department e.g. WH for
whole plant and QC for Quality Control and so on.
5.1.3.4 Fifth, Sixth and Seventh character shall denotes the serial number of the tape.
5.1.3.5 Eighth character shall be a dash “-”.
5.1.3.6 Ninth and tenth character shall be the last two digits of the calendar year e.g. 15 for 2015
and 16 for 2016.
5.1.3.7 Eleventh character shall be “A” for Tape 1 and “B” for tape 2.
5.1.3.8 Tape 1 shall be retained at plant while tape 2 shall be retained with IT department at other
locations of pharmaceutical company in fireproof area.
5.1.3.9 Each department personnel shall store the data (Data whose backup is to be taken) in Z
drive of their system.
5.1.310 IT personnel before taking the backup shall intimate all the users well in advance
regarding the date of taking the back by electronic means.
5.1.3.11 IT personnel shall affix the number on the tape in the space already provided on the
tape.
5.1.3.12 IT personnel shall record the number allotted to the particular tape on Annexure-1.
5.1.3.13 IT personnel then take the backup using NT backup software
5.1.3.13.1 Backup procedure: Choose the network drive to backup with verification option
5.1.3.13.2 After completion of backup, check the automated reports for any error.
5.1.3.13.3 On finding the error, replace the faulty tape with a new tape.
5.1.3.13.4 Assign the same number to the new tape.
5.2 For QC department
5.2.1 Frequency: Monthly
5.2.2 Numbering procedure for the tapes shall remains as per point number 5.1.3.
5.3 Storage of the backup data

5.3.1 Every backup shall be taken in doublet; Tape-1 shall be retained at plant under the
authorization of Head-QA in a separate fireproof, lock and key arrangement, while Tape-2 shall
be retained under the same conditions under the custody of Head-IT/Designee at other location.
5.3.2 Tape 2 shall be retrieved from IT personnel prior to destruction; also both tapes shall be
destroyed at the same time.
5.3.3 Every tape shall be retained for a period of not less than six years, after six years
destruction of the same shall be done under the supervision of Head-QA/Designee and Head-
IT/Designee.
5.3.4 Destruction record shall be retained with QA documentation cell.
Note: In case some data has lost from any system; the concerned department head/designee (In
absence only) shall raise a request (Annexure-3) and send the same to Head-QA/Designee (In
absence only) for the approval with proper justification; only after the approval from QA, Head-
IT/Designee shall upload the required data to the user system
Note: Backup shall be taken by IT personnel through single user id i.e. from Administrator login
id only.
Electronic data backup record – Annexure-1
Destruction record – Annexure-2
Request form – Annexure-3
7.0 Distribution
Master copy – Documentation Cell (QA)
Controlled Copies – Quality Assurance, Information technology and Quality Control
8.0 Reference:
If any
9.0 History

– – New SOP
Annexure-1
Electronic data backup record
Tape Number
Backup taken Verified by(QA
S.No. Serial Number Number allotted by Backup Date
by(IT personnel) Personnel)
of the tape IT personnel

Annexure-2
DATA DESTRUCTION RECORD
Date Tape Number Due Destruction Date Destroyed by Verified by Remarks

Annexure-3
Request Form
For reloading the data in the system
From: Concerned department
Name : ___________________________
Designation : ___________________________
Department : ___________________________
Sign. /Date : ___________________________
Justification for reloading and reasoning for data lost:
______________________________________________________________________________
______________________________________________________________________________
____________________________________________________________
Approved By
Head-QA/Designee
Name : __________________________
Sign. /Date : __________________________
Data Reloaded By
Head-IT/Designee
Name : ___________________________
Sign. /Date : ___________________________
SOP for Management of Equipment
Objective
To lay down a procedure for Management of Equipment.
Scope
This SOP is applicable for Management of Equipment.
Responsibility
Respective heads of user departments shall be responsible of this procedure.
Accountability
Abbreviations and Definitions
Equipment : An instrumentality needed for an undertaking or to perform a service.
In this SOP, term equipment shall be commonly used for all Machines, Instruments and
Equipments installed in all departments.
Procedure
 All new Equipments shall be procured through Materials Management through a

qualification process where in user requirement specifications, design qualification may
be done as part of impact assessment process on the product quality.
 Equipment numbering of the Equipments shall be assigned by respective department
heads as per SOP No. BF-QA-001. Equipment number shall be displayed prominently on
each equipment.
 The equipments shall either be commissioned as per Goods Engineering Practices or
qualified through Installation Qualification, Operational Qualification and Performance
Qualification.
 All equipments installed in manufacturing area, shall have a user log as ‘Machine Log
Sheet’, which shall include duration of machine usage, machine cleaning, breakdown and
preventive maintenance as per the Annexure-1.
 For the chain of equipments placed in a single area depicting a single work station jointly
and are supposed to be used on a single product at a time, a single Machine Log Sheet
with details of all equipments with their identification number can be used.
 Equipments in routine use shall be maintained through intermittent calibration,
preventive maintenance program and revalidation procedure.
 Practice of appropriate labeling on equipment shall be maintained depicting the ‘status’
of equipment. Besides ‘status’ the label shall include the other information like
equipment ID number, its location, Signature & Date.
 Spare machines shall be labeled as ‘Not in Use’ and shall be placed in the designated
area.
 Routine calibration of the critical parameters of the equipments shall be stopped during
the ‘Not in Use’ period, until the equipment is made functional.
 If any equipment is redundant or not for use or damaged beyond any repair, the same
shall be labeled as ‘Rejected’ and shall be removed from the site with proper
authorization from QA. Equipment list shall be updated accordingly. Written records
thereof shall be maintained.
Forms and Records (Annexures)
Machine Log Sheet : Annexure – 1
Distribution
Master Copy – Documentation Cell (QA)
Controlled Copies – Production, Quality Control, Stores, Engineering,

Administration and Housekeeping
Reference:
If any
8.0 History

– – New SOP

MACHINE LOG SHEET
Area/Room Name/No. Equipment Name Equipment No

Month and Year
OPERATION CLEANING MAINTENANCE C.

DONE
DATE PRODUCT B.NO TYPE REMARKS
FROM TO FROM TO FROM TO BY
A/B BY

Write “-“where not applicable
SOP on Repackaging / Re-labeling of Finished Goods
1.0 Objective
To lay down a procedure for Repackaging / Re-labeling of Finished Goods.
2.0 Scope
The scope of this standard operating procedure is applicable for Finished Goods which are either
Returned or Existing Stocks; and marketed by pharmaceutical company which are either
received and kept in Central Warehouse of pharmaceutical company.
3.0 Responsibility
Officer/Executive Production for planning, control and overprinting the packing material as per
this SOP.
Officer/Executive Stores shall be responsible for issuance of material to production and dispatch
of released material to CWH
Officer/Executive IPQA/QA for implementation of procedure as per this SOP.
Head QA shall be responsible for compliance of this SOP.
RP – Retail Price
DP – Designated Personnel

CWH – Central Warehouse
IPQA – In-process Quality Assurance
TD – Technical Direction
BMR – Batch Manufacturing Record
Returned Goods – Goods received by central warehouse due to change in price (Retail price
– RP) or damaged due to soiled labels rendering the product(s) aesthetically Un-presentable, but
otherwise clearly identifiable.(Need redressing / Repackaging / Re-labeling.
Existing Goods – Goods present in central warehouse but damage due to environmental
conditions Leading to Mutilated / Smudged labels rendering the product (s)aesthetically Un-
presentable but otherwise clearly identifiable ( need redressing / Repacking / Re-labeling.
Repackaging/Re-labeling – Repackaging or otherwise changing the container, wrapper, or

labeling of any device package in furtherance of the distribution of the product from the original
place of manufacture to the person who makes final delivery or sale to the ultimate consumer.
5.0 Procedure For Repackaging/ Relabeling of Returned Goods
5.1 On receipt of “Returned Goods Form” from CWH for Returned Goods which are Damaged
due to Soiled Labels rendering Product(s) Aesthetically Un-presentable but otherwise clearly
identifiable ,QA shall assign number to the form as per SOP.
5.2 Quality Assurance personnel shall inspect the goods at Warehouse and record the findings in
“Returned Goods Form” in case of Returned Goods in Annexure- 1.
5.3 QA Personnel in presence of Production Personnel shall verify full stock of returned goods
by opening the consignment e. checking the corrugated boxes , cartons , mono cartons , labels ,
Strips etc for any kind of Damage and note down the observations noticed with Date in
Annexure –2,3 as per type of Activity to be performed in according to Consignment which was
dispatched earlier
5.4 Proper Reconciliation of material during activity shall be recorded in Annexure-2,3& and
further request for repacking/ relabeling of material shall be forwarded to Stores.
5.5 QA shall Authorized and Production should give request to Stores for Further issuance Of
material required for Repackaging/ Relabeling of the Finished Goods in Annexure -5 after
reconciliation of material as per Annexure-2,3 respectively.
5.6 The “Returned goods Form” shall be forwarded (if required) to the concerned and /or
relevant department for their comments. A separate sheet may be attached for comments, if space
is insufficient.
5.7 After comments from each department, the concerned forms shall be sent back to QA for
review and Approval.
5.8 Head QA or his/her designee shall evaluate the findings, and approve or Un-approve the
forms for Repackaging/re-labeling or destruction of the returned goods.
5.9 If the “Returned Goods Form” is approved for Repackaging/re-labeling, Production shall
send a request to Stores manager to plan inventory and printing activity on “Repackaging / Re-
labeling request Form” (Annexure-3).
5.10 QA personnel shall assign a serial number to “Repackaging / Re-labeling request Form”.
5.11 The “Repackaging / Re-labeling request Form” shall include the details like Product Name,
Batch Number, Mfg. Date, Exp. Date, Pack size, Pack for Sale/PS/Government Supply, Market,
Packaging Formula Number and Quantity to be repacked.
5.12 Production Manager in co-ordination with Stores Manager shall plan the Repackaging
activity depending on availability of facility and packaging material and enter date in designated
place in the form.
5.13 Production manager and Stores Manager shall duly sign. their acceptance in designated
column in “Repackaging / Re-labeling request Form”.
5.14 On receipt of form back from Production manager and Stores Manager, QA personnel shall
re-issue the BMR as per SOP-AF-QA-011, a copy of packaging TD along with required formats
to production.
5.14.1 Each page of new packaging TD and Formats shall be duly Stamped with “Repackaging /
Re-labeling stamp”:
FOR REPACKAGING / RE-LABELING PURPOSE ONLY
5.15 “Repackaging / Re-labeling request Form” shall be affixed in the BMR.
5.16 The production department shall fill the required details like item code of packing material,
quantity, etc. in packaging order of packaging TD and send the same to stores for issuance.
5.16.1. Stores before Issuing of Packaging Material to production should make entry in there
records in concern to “RETURNED GOODS”.
5.16.2 Packaging order shall be filled for required quantity plus 2 % extra packaging material.
This is required to compensate losses during printing and packaging
5.17 All the manufacturing activity shall be done through Line Clearance procedure as per
respective SOP.
5.18 After issuance of packing material from stores, necessary information shall be filled in
TD by Stores personnel and BMR shall be sent back to production.
5.19 Production shall plan overprinting activity in the designated area. Line clearance shall
be given by IPQA as per respective SOP.
5.20 Production supervisor shall fill the packaging information in packaging TD.
5.20.1 All the In-Process checks shall be performed as mentioned in the TD
5.20.2 Only those steps shall be filled in packaging TD those are applicable to the process.
5.20.3 For those steps which are shall be ‘Not Applicable’ “N.A.” shall be written.
5.21 After completion of activity the material shall be verified by IPQA and released by Head
QA for transfer to Stores.
5.22 Officer/Executive Stores shall dispatch the material to CWH.
5.23 All the Repackaging / Re-labeling related documents/Formats shall be attached in

Original BMR of respective batch number.
5.24 if required at CWH the Repackaging activity for tertiary packaging material shall be done
by DP in presence of QA personnel.
5.25 Procedure for Repackaging/ Relabeling of Existing Goods
5.26 On receipt of “Existing Goods Form” from CWH for Existing Goods which are
Damaged due to environmental conditions Leading to Mutilated / Smudged labels rendering
the product (s)aesthetically Un-presentable but otherwise clearly identifiable ( need
redressing / Repacking / Re-labeling.
5.27 Quality Assurance personnel shall inspect the goods at Warehouse and record the findings,
in “Existing Goods Form” in case of Existing Goods in Annexure – 6.
5.28 QA Personnel in presence of Production Personnel shall verify full stock of Existing goods
by opening the consignment e. checking the corrugated boxes ,cartons ,mono cartons , labels ,
Strips etc for any kind of Damage and note down the observations noticed with Date in
Annexure–2,3 as per activity performed in according to Consignment which was dispatched
earlier.
5.29 QA shall Authorized and Production should give request to Stores for Further issuance of
material required for Repackaging/ Relabeling of Existing Goods.
5.30 The “Existing goods Form” shall be forwarded (if required) to the concerned and /or
relevant department for their comments. A separate sheet may be attached for comments, if space
is
5.31 After comments from each department, the concerned forms shall be sent back to QA for
review and Approval.
5.32 Head QA or his/her designee shall evaluate the findings, and approve or Un-approval the
forms for Repackaging/re-labeling or destruction of the Existing goods.
5.33 If the “Existing Goods Form” is approved by QA for Repackaging/re-labeling, Production

shall send a request to Stores Manager to plan inventory and printing activity on “Repackaging /
Re-labeling request Form” (Annexure-5).
5.34 QA personnel shall assign a serial number to “Repackaging / Re-labeling request Form”.
5.35 The “Repackaging / Re-labeling request Form” shall include the details like Product Name,
Batch Number, Mfg. Date, Exp. Date, Pack size, Pack for Sale/PS/Government Supply, Market,
Packaging Formula Number and Quantity to be repacked.
5.36 Production Manager in co-ordination with Stores Manager shall plan the Repackaging
activity depending on availability of facility and packaging material and enter date in designated
place in the form.
5.37 Production manager and Stores Manager shall duly sign. their acceptance in designated
column in “Repackaging / Re-labeling request Form”.
5.38 On receipt of form back from Production manager and Stores Manager, QA personnel shall
re-issue the BMR as per SOP, a copy of packaging TD along with required formats to
production.
5.38.1 Each page of new packaging TD and Formats shall be duly Stamped with “Repackaging /
Re-labeling stamp”:
FOR REPACKAGING / RE-LABELING PURPOSE ONLY
5.39 “Repackaging / Re-labeling request Form” shall be affixed in the BMR
5.40 The production department shall fill the required details like item code of packing material,
quantity, etc. in packaging order of packaging TD and send the same to stores for issuance.
5.41 Stores before Issuing of Packaging Material to production should make entry in there
records in concern to “RETURNED GOODS.
5.42 Packaging order shall be filled for required quantity plus 2 % extra packaging material.
This is required to compensate losses during printing and packaging
5.43 All the manufacturing activity shall be done through Line Clearance procedure as
per respective SOP.
5.44 After issuance of packing material from stores, necessary information shall be filled in
TD by Stores personnel and BMR shall be sent back to production.
5.45 Production shall plan overprinting activity in the designated area. Line clearance shall
be given by IPQA as per respective SOP.
5.46 Production supervisor shall fill the packaging information in packaging TD
5.46.1 All the In-Process checks shall be performed as mentioned in the TD
5.46.2 Only those steps shall be filled in packaging TD those are applicable to the process
5.46.3 For those steps which are shall be ‘Not Applicable’ “N.A.” shall be written
5.47 After completion of activity the material shall be verified by IPQA and released by
Head QA for transfer to Stores.
5.48 All the Material shall be destroyed as per Reconciliation of material for destruction
in Annexure-4
5.49 Officer/Executive Stores shall dispatch the material to CWH
5.50 All the Repackaging / Re-labeling related documents/Formats shall be attached in

Original BMR of respective batch number.
5.51 If required at CWH the Repackaging activity for tertiary packaging material shall be
done by DP in presence of QA personnel.
6.1 Returned Goods Form – Annexure – 1
6.2 Observations during Decartoning of goods to be Repacked/Relabeled – Annexure -2
6.3 Observations during Defoiling of goods to be Repacked/Relabeled – Annexure-3
6.4 Reconciliation of materials for Destruction – Annexure-4
6.5 Repackaging / Re-labeling Request form – Annexure – 5

6.6 Existing Goods Form – Annexure – 6
7.0 Distribution
8.1 Master Copy – Quality Assurance (Documentation Cell)
8.2 Controlled Copies – Production, Store, Central Goods Warehouse, Quality Assurance
8.0 History

– – New SOP
RETURNED GOODS FORM
Serial No: Date:
Warehouse Signature Date:

Date Exp. Quantity
Product/(s) Batch No Date Mfg.
Class

Quality Control department findings.

QC Personnel Head of
Department
(Sign / Date) (Sign / Date)

Other Department Findings
Head of Concerned Department
(Sign & Date) (Sign / Date)

Disposition by Quality Assurance
Head of QA
(Sign /Date)

Annexure-2
Observations During Decartoning of Goods To Be Re-Packed / Re-Labeled
Product Name : —————————- Product Code: ———————-
Mfg. Date : ————————— Exp. Date : ———————–
Batch No. : ————————– Batch Size : ———————–
Type of Goods (Returned / Existing) : ———————————-
Type of Activity to be Performed : ———————————–
Packing Configuration :

————————————
Area/ Room No. : ————————————-
Date of No. of good

Start No. of
No. of strip/ No. of Activity
Time End Shipper Strip/blister/
Activity cartons blister/ Strip/blister/bottle Performed
Time No. bottle
received bottle rejected By
received
found

After Reconciliation,
Total Qty. of material received =
Total observed Good qty. of material after Decartoning =
Total Rejections during activity =
Checked By (Production):—————- Verified By QA :

——————-

* Before performing activity line clearance to be taken as per respective SOP.
Annexure-3
Observations During Defoiling of Goods To Be Re-Packed / Re-Labeled
Product Name : ——————— Product Code: ——————–
Mfg. Date : ——————— Exp. Date : ——————-
Batch No. : ——————– Batch Size : ——————
Type of Goods (Returned / Existing) : ——————-
Type of Activity to be Performed : ——————-
Packing Configuration : ———————
Area/ Room No. :——————-
Persons
Date of Date of
Persons involved in
Defoiling Start End Visual
EQ. ID. involved in Start End EQ.ID Visual
Time Time Inspection
defoiling Inspection of
of Tablets
Tablets

After Reconciliation,
Tablet Received after Defoiling =
Good tablet received after visual inspection =
Total Rejections during activity =

Checked By( Production):————– Verified By QA :

————
Before performing activity line clearance to be taken as per respective SOP.
Annexure-4
Reconciliation of Materials for Destruction

Product Name : ——————— Product Code: ——————–
Mfg. Date : ——————— Exp. Date : ——————-
Batch No. : ——————– Batch Size : ——————

Date of Material to be No. of Quantity Destruction Destruction End Persons Involved in

Destruction Destroyed to be destroyed Start Time Time Destruction

Checked By( Production):————– Verified ByQA :
————

Note: * Before performing activity line clearance to be taken as per respective SOP.
Repackaging / Re-labeling Request Form
Serial Number: __________________________ Date:

_______________
From: Production Department
Requested By (Name/Sign./Date):_________________________
To,
Stores Manager
Pharmaceutical Company
Subject: Request for plan of Re-Packing/Re-Labeling
Sent To: Quality Assurance / Stores Department

Against
Pack (PS / Quantity to be
Product Batch Mfg. Exp. Pack Packaging
Sales / Govt. Market repacked/re-
Name Number Date Date Size Formula
Supply) labeled
No.

Acceptance by Stores Manager (Sign./Date ): ___________________________
Date of Re-packing Plan :___________________________
Approval By QA Head (Sign./Date ) :____________________________
EXISTING GOODS FORM
Serial No: Date:
Warehouse Signature Date:

Product/(s) Batch No Date Mfg. Date Exp. Quantity Class

Quality Control department findings.
QC Personnel Head of
Department
(Sign / Date) (Sign / Date)

Other Department Findings
(Sign & Date) (Sign / Date)

Disposition by Quality Assurance

Head of QA
(Sign /Date)
Review, Storage, Retrieve and Disposal of Executed Batch Documents
Objective
To lay down the procedure for Review, Storage, Retrieval and disposal of Executed Batch
documents.
Scope
This SOP covers the procedures for Review, Storage, Retrieval and disposal of Executed Batch
documents in pharmaceutical company
Responsibility
Quality Assurance /Officer and production chemist shall be responsible for following the
procedure mention in this SOP.
Production mfg. chemist and QA executive shall be responsible for compliance of this SOP.
Accountability
Head Production and Quality Assurance accountable for implementation of this SOP.

BMR : Batch manufacturing record
COA : Certificate of analysis
Procedure
 Check the executed BMR after completion of batch shall have containing all sheets as
issued.
 Ensure that the following sheets are attached along with BMR that is Raw material
requisition slip, Raw material issue note, Raw material issued to production (dispensing
sheet), Packing material requisition slip, Packing material issue note, Packing material
return from production, Packaging coding control record, manufacturing & packing
process details, finished product analysis report, Product re-conciliation sheet, Post- batch
line clearance record (QA), Release order and finished Goods Transfer Note.
 Review the recording of entire activity in BMR and verify the data in calculations &
reconciliation of the manufacturing and packing operations in the respective documents.
 Ensure that all activities of the process operations has been recorded as specified in
documents and no place for recording or verification is left unaddressed. Verify that
entries are made for “Done By” & “Checked By” for different activities and timings are
entered accordingly.
 Check and verify the yield reconciliation at respective stages of the processing as shown
in BMR with respect to inputs and expected standard yields.
 Ensure that yield at various stages are within the specified limits. Any deviation from
specified limit for yield is investigated, and yield deviation report is approved by QA
Manager.
 Check and verify the primary, secondary packing material as shown in BPR. Ensure that
any deviation from specified limit is investigated and approved by QA Manager.
 Ensure that in process checks during manufacturing and packaging are properly
documented and are found within specified limits.
 Verify the COA with respect to their respective specifications of the final analysis of
finished products.
 Compile the Batch manufacturing and packing records along with the analytical
documents, in-process reports.
 Punch all components and enclosures of the BMR & COA kept together.
 Ensure that BMR are stored in the Documentation Room under locked conditions and the
key is available with the Documentation Executive / Officer & QA Manager.
 Ensure that the BMR are accessible to person other than QA Executives / Officers only
after authorization from the QA Manager.
 Ensure that BMR are preserved for a period of 01 years from the date of expiry of the
batch.
 After the storage period of BMR is over, the documents are shredded in a paper
shredding machine in the presence of QA Executive / Officer but only after an
authorization from QA Manager.

 Checklist of attached review documents – Annexure-I
 Distribution
o Controlled copies- Quality Assurance, Production, Quality Control, Stores.
9.0 History

– – New SOP
Annexure – I
Product : B.No. : B.Size:

Date of Mfg. Date of Exp.
S. No Particular OK Not OK NA Remarks
Check the Executed of Batch Manufacturing
1.0
record (BMR) are containing all sheets as issued.
2.0 Line clearance checklist of all stage
3.0 Raw material requisition slip
4.0 Raw material issue note
Raw material issued to production (dispensing
5.0
sheet)
6.0 Packing material requisition slip
7.0 Packing material issue note
8.0 Packing material return from production
9.0 Packaging coding control record
10.0 Manufacturing & packing process details
11.0 (A) For Ointment
11.1.1 Bulk product preparation & sampling
11.1.2 Bulk product analysis report
11.1.3 Filling and crimping of tubes
11.1.4 In-process control record
11.1.5 Packing & FG sampling
11.1.6 In-process packing control record
11.2 (B) For Tablets
11.2.1 Dry blending & granulation
11.2.2 Wet screening and drying of granules
11.2.3 Lubrication & bulk sampling
11.2.5 Tablets compression record
11.2.6 In-process control record
11.2.7 Tablets coating record
11.2.8 Blistering, packing and FG sampling
11.3 (C) For Syrups
11.3.1 Sieving, mixing and bulk sampling
11.3.2 Bulk product analysis reports
11.3.3 Cleaning & inspection of cleaned bottles
11.3.4 Filling, sealing ,labeling and inspection
11.3.5 In-process weight check record
11.3.6 In-process weight check record
11.3.7 Packing and FG sampling
11.3.8 In-process packing control record
S. No Particular OK Not OK NA Remarks
11.4 (D) For Injection area
11.4.1 Washing and sterilization of ampoules/ vials
Washing & sterilization of rubber stoppers/
11.4.2
filling nozzles/ pumps etc.
11.4.3 Mixing ,homogenization & filtration
11.4.4 Blending & bulk sampling
11.4.6 Filling & sealing record
11.4.7 Volume / weight check record
11.4.8 Terminal sterilization of finished product
11.4.9 Visual inspection duty
11.4.10 Visual inspection of filled amps./ vials
11.4.11 Labelling, packing and FG sampling
11.5 (E) For Oral liquids
11.5.1 Mixing, homogenizing and bulk sampling
11.5.3 Washing and inspection of washed bottles
11.5.4 Filling ,sealing, labelling and inspection
11.5.5 In-process volume check record
12.0 Finished product analysis report
13.0 Product re-conciliation sheet
14.0 Final yield
15.0 Post- batch line clearance record (q.a.)
16.0 Release order
Review by (Production) Checked by
(QA)
Sign/Date Sign/Dates
Sop on Rejection and Destruction Policy of Drug Products and its

Components
1.0 Objective
To establish the guidelines for destruction of drug products and its components.
Scope:
This sop shall be applicable for rejection, collecting, accounting & safe destruction of rejects, un-
recoverable and expired pharmaceutical products and its components at various stage in
pharmaceuticals company.
Responsibilities:
QA / production / warehouse / personnel & administration officer or above shall be responsible

for rejection, destruction of rejected, unrecoverable and expired drug products & its components.
Accountability:
Head – QA shall be accountable for compliance of sop.
5.0 Abbreviations and Definitions:
SOP : Standard Operating Procedure; a document where step by step instructions are cited to
serve as support for methods or manners of fulfilling a function or functions reliably and
consistently.
ETP : Effluent Treatment Plant
NAOH : Sodium Hydroxide
6.0 Procedure:
6.1 Rejection and destruction of packing material:
6.1.1 Destruction of the printed packing materials from the shop floor:
6.1.1.1 Following printed packing materials shall be subjected for destruction on the shop floor.
i. Wrong or smudged overprinting labels, cartons, catch covers and show boxes which are
rejected while over printing the batch details.
ii. Wrong or smudged overprinted labels, cartons, catch covers and show boxes that are rejected
on packing line.
6.1.1.2 Procedure for the destruction of paper / card board type of printed packing material from
shop floor.
i. The packing supervisor shall make entries in the register book as well as on the batch card for
accounting the overprinting packing materials which shall be destroyed
ii. At the end of batch, the rejected printed packing materials shall be destroyed by shredding
them off or subjecting to shredding machine, if available in the presence of a Q.A. Officer.
iii. The torn rejected printed packing material shall be transferred to the scrap yard.
iv. The personnel & administration officer shall ensure that these torn printed packing materials
are taken outside the factory premises at suitable interval and are further destroyed by burning /
shredding them at a safe place.
v. This operation shall be carried out after taking approval from Q.A.
6.2 Procedure for the destruction of printed, plain aluminum / pvc foils, rejected ropp caps,
measuring cups, HDPE bottles, flip off seals glass bottles and vials from the shop floor:
6.3 Following packing materials shall be subjected for destruction on the shop floor.
i. Wrong or smudged overprinting foils which are rejected while over printing the batch details.
ii. De shaped or with other manufacturing and processing defects in ropp caps, measuring cups,
HDPE bottles, flip off seals glass bottles and vials that are rejected on packing line.
6.3.1 The production officer shall make entries in BMR/BPR for accounting the rejeced packing
material which are to be destroyed.
6.3.2 At the end of the batch, the shift production supervisor shall ensure that the printed
aluminum and pvc for blister and strips shall be destroyed by cutting the roll into pieces or
subjecting it to shredding machine, if available. Carry out this operation in the presence of a Q.A.
Officer.
6.3.3 The cut foil shall be transferred to the scrap yard.

6.3.4 The line rejected ropp caps, measuring cups, HDPE bottles, flip off seals glass bottles and
vials shall be destroyed by crushing / de-shaping them.
6.3.5 Apart from approvals from concerned production supervisor, it shall be the duty of the
security officer / guards to ensure that no intact / filled bottles / vials are taken to the scrap yard.
6.4 Destruction of the printed packing materials from the warehouse
6.4.1 Any fresh material if rejected due to printer’s mistake than the printer shall do the sorting
of packaging components. Sorted good and the rejected lots shall be destroyed.
6.4.2 If the material can not be salvaged and can not be reused, then it shall be destroyed by
suitable destruction procedure.
6.4.3 The packing material stores supervisor shall ensure to take in writing from the supplier
stating that the printed packing material shall be destroyed in his presence, along with the name
of the product, type of packing material, quantity, date and the place where the printed packing
material shall be destroyed.
6.4.4 In the event of introduction of new type of material, all the old type of printed packing
materials shall be destroyed as above and recorded.
6.5 Procedure for destroying the printed packing materials from the warehouse:
6.5.1 If the printed packing material which is to be destroyed is a modvat item, then the packing
materials warehouse supervisor shall intimate the finished goods warehouse supervisor for taking
the permission for its destruction from the excise department.
6.5.2 Destroy the printed packing materials by subjecting it to shredding machine, if available. In
case the shredding machine is not available then the packing materials destroy by manual
cutting. Carry out this operation in presence of a security personnel and intimate qa department
for verification.
6.5.3 If the printed material is destroyed by manual cutting, then after the distruction operation is
over, recording of the above shall be done.
6.5.4 If large quantities of printed foils are rejected then these can be returned to the supplier, for
the printed matter erasing under non-returnable gate pass.
6.6 Disposal of rejected raw materials from the warehouse:
6.6.1 Disposal of the rejected raw materials on party’s account shall be done if the raw-material
is rejected by the quality control department. Then the party shall lift the material from
quarantine.
6.6.2 Disposal of the rejected raw material on company’s account.

6.6.3 After taking approval as per annexure rejected raw materials, which are lying in raw
material store, shall be lifted for disposal.
6.6.4 Upon receiving the approval for the disposal, proper documentation / records shall be
maintained.
6.6.5 Before destroying the active material, de-activate them using 2% NAOH solution.
6.7 Destruction of expired / recalled/ rejected products from the finished goods warehouse:
6.8 Reasons of rejections of finish good.
 Wrong overprinting of the batch details.

 Fail in finish good testing by Q.C.
 Recalled products in which corrective action and rework not possible.
 Not released for dispatch and rejected by Q.A. head.
6.8.1 Before destroying the expired / rejected / recalled drug material from finished goods store,
approval shall be taken from plant head and head – Q.A.
6.8.2 After receiving their approval, the finish goods are de-foiled / de-bottled / de-vials.
6.8.3 The de-foiled / de-bottled / de-vials drug products are then de-activated by treated with 2%
NAOH solution.
6.8.4 The treated material is then drained into ETP. The record for the same is maintained.
6.8.5 Packing materials destroy as per procedure and transfer in scrap yard.
6.9 Destruction of non-recoverable material generated during manufacturing:
6.10 Reasons for non recoverable rejection.
 Handling loss during manufacturing.

 Material found out of specification for example lump formation.
 Some kind of contamination or impurity observed.
6.10.1 The non-recoverable product (intermediate product) like; tablets, capsules, lubricated
blend etc. Shall be destroyed after de-activating with 2% NAOH solution.
7.0 List of Annexure / Formats:
Authorization For Destruction – Annexure – I

 SOP for collection and disposal of waste & rejected material from plant.
 SOP on destruction and disposal of media filled vials
 SOP for disposal of rejected primary and secondary packing materials.
 SOP on withdrawal, storage, observation & destruction of control / retention sample.
 SOP on inventory, storage issuing and destruction of rubber stereos
 Sop on handling rejected raw materials.
 Sop on rejected packaging material.
 Sop for handling of scrap.
8.0 Distribution
8.2 Controlled copies- Quality Assurance, Personnel and Administration, Production-Oral and
Ware house
9.0 History

– – New SOP
Annexure – I
Authorization for Destruction
Product: Batch no.: Batch size:
1.0 Details of the material to be destroyed:
Materials Make Quantity
2.0 Reason for destruction :
3.0 Cost involved :

4.0 Detailed investigation report :
Investigated by:
5.0 Method of destruction :
Proposed by Approved by Authorized by
6.0 Destruction details :
Destroyed by Checked by Verified by
Corrective and Preventive Action (CAPA)
1.0 Objective
To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes
of potential non-conformities and /or encountered non-conformities in order to prevent their
occurrence and / or recurrence.
2.0 Scope
This Standard Operating Procedure shall apply to all corrective and preventive action taken in
pharmaceutical formulation company.
3.0 Responsibility
 Concerned Department Head and QA Head shall be responsible for identifying the need
for CAPA.
 Concerned Department Head and QA Head shall be responsible for completion of the
proposed CAPA.
 QA Head shall be responsible for ensuring that all CAPA identified during all
investigative processes are included, maintained and updated in the record of corrective
and preventive action.
4.0 Accountability
QA Head/ designee shall be accountable for implementation of this SOP.
CAPA : Corrective Action and Preventive Action

Non-conformities in products, manufacturing process, SOP, utility,
Non-
: equipment, building and facilities with respect to predetermined
conformities
acceptance criteria, specification, or cGMP elements.
The action taken to eliminate the causes of an existing non-conformity,
Corrective defects or other undesirable situation in order to prevent recurrence, to a
:
Action degree appropriate to the magnitude of problems and adequate with the
risks encountered.
The action taken to eliminate the causes of a potential non-conformity,
Preventive defects or other undesirable situation in order to prevent occurrence, to a
:
Action degree appropriate to the magnitude of problems and adequate with the
risks encountered.
6.0 Procedure
6.1 Initiation of CAPA:
6.1.1 The Concerned Department shall identify and clearly define the potential non-conformities
and/or review encountered non-conformities arising out of procedures like Handling of
Deviations in Facility, Standard Operating Procedures, Batch Manufacturing Record and
Specifications; Internal Audits; Change Control; Handling of Product Complaints; Product
Recall; Handling of Non-conforming In-process and Finished products; non-conforming delivery
from vendors, etc.
6.1.2 The Concerned Department along with any other relevant department, if applicable, shall
determine the causes of non-conformities.
6.1.3 The Concerned Department shall submit the corresponding document or source document
(e.g NCR form, Complaint Information Form, Deviation Report, Internal Audit Report, Product
Recall – Investigation and Disposition, Change Control etc.) to QA Head.
6.1.4 QA Head along with Concerned Department Head shall decide the need for the CAPA. If
need identified than QA personnel shall issue the CAPA Form (Annexure –I) and allot the
CAPA No., as CAPA/XXX/YY, where:
CAPA – Corrective and preventive action
“/” – ‘Slash’
XXX – Serial number, commencing from 001 in calendar year
YY – Last digit of calendar year.
e.g.: CAPA/002/16 represents 2nd CAPA in calendar year 2016.
And make relevant entries in the logbook titled “Record of Corrective and Preventive Action ( as
per Annexure –II).
6.1.5 After assigning the CAPA No. QA Personnel shall write the details of the corresponding or
source document (name & number).
6.1.6 The CAPA Form then shall be forwarded to the Concerned Department.
6.1.7 The Concerned Department shall fill in the form the description of identified non
conformity and necessary corrective action taken and intimate to QA for verification.
6.1.8 QA personnel shall verify the non-conformity, corrective action with their impact and put
their signature with date in relevant column.
6.1.9 After that Concerned Department Head shall carried out investigation to identify the cause
of the non-conformity along with verification from QA Department.
6.1.10 During investigation if required concerned department shall take the comments from any
other department.
6.1.11 These all investigation and comments of other department shall be verified by QA along
with sign & date.
6.1.12 After completion of investigation a proposed preventive action shall be identified with
their target completion date.
6.1.13 In case the proposed preventive action is not completed due to genuine reason than target
completion date shall be revised by taking permission of QA Head.
6.1.14 A proper justification or reason for revised target date shall be given by Concerned
Department which shall be verified by QA department.
6.2 CAPA Closure and Verification:
6.2.1 On the target completion date the Concerned Department Head shall verify that the
proposed CAPA is completed within the specified time period and implemented along with
associated actions.
6.2.2 QA Head shall evaluate the implementation of proposed action within the target
completion date and completion of CAPA form by reviewing of supporting documents
6.2.3 If any change proposed as a result of CAPA shall be done through SOP on Change Control
and reference of the same shall be mentioned in the CAPA format.
6.2.4 All change controls, deviations, discrepancies, NCR, incident reports giving rise to CAPA
shall be addressed through CAPA form.
6.2.5 The record of each CAPA shall be maintained.
6.2.6 After doing all above given activities CAPA shall be closed by Head QA.
7.1 CAPA Form : Annexure -I
7.2 Record of Corrective and Preventive Action : Annexure -II
7.3 Decision Tree : Annexure -III
8.0 Distribution
8.2 Controlled Copies – Quality Control, Quality Assurance, Stores,
Production, Engineering.
9.0 History

– – New SOP
Annexure-I
Initiation Date:
CAPA No.:

Department :
Corresponding Document Name:
Corresponding Document No.:

Description of Non-conformity (from corresponding recording document) :
Corrective Action Taken/ Proposed:0
Head of Concerned department
(Sign /Date)

Verified By QA
Sign/Date
Investigation of non-conformity

Head of Concerned department
(Sign /Date)
Comments from other department (If required)
Head of department
(Sign /Date)
CAPA No.:
Verified by QA
(Sign/Date)
Proposed Preventive Action:
Target Completion Date:

Revised Target completion Date ( If any):
Reason for revision:
Head of Department Verified By

QA
(Sign /Date) (Sign

/Date)
Evaluation & review of implemented Preventive Action:
(Sign /Date)
Head QA
(Sign/Date)
Note: If space is insufficient for recording the information, the same can be recorded in extra
sheet duly signed.
Annexure -II
Source Evaluation and

CAPA Initiation Completion Reason for Compiled by
Dept. Document Review of CAPA
No. Date Date CAPA (Sign/Date)
Number By Date

Annexure -II
SOP For House Keeping Personnel Movement in Manufacturing Facility
1.0 Objective:
To lay down a procedure for house keeping personnel movement
2.0 Scope:
This SOP is applicable to house keeping personnel for guiding them concerning their movement
in manufacturing facility (Production – Oral & Ware house) in pharmaceutical company.
3.0 Responsibility
3.1 House keeping personnel is responsible for cleaning of respective areas
3.2 In charge – Housekeeping is responsible for cleaning of respective areas and coordination for
their movement
3.3 Officer/Above of concerned department is responsible for monitoring effectiveness of

cleaning
4.0 Accountability
Head of concerned department/Head-QA shall be responsible for compliance of SOP

consistently.
No. : Number
6.0 Procedure
6.1 Every house keeping personnel must maintain hygienic condition as per SOP on Health and
hygiene of plant personnel.
6.2 Every house keeping personnel shall under go for training for the functions
6.3 Every house keeping personnel shall be aware of entry and exit procedures of applicable
areas as per respective SOP’s.
6.4 Before taking cleaning activity, the house keeping personnel shall follow good gowning
practices like cleaned garments, eye goggles, hand gloves, nose masking, booties/ plant
footwear.
6.5 House keeping personnel shall perform their activities by following SOP for cleaning of
packing hall, ware house and change room and SOP for cleaning of primary production area.
6.6 Disinfectants used for cleaning shall be rotated on weakly basis as per SOP on disinfectant
usage policy.
6.7 House keeping personnel is requested to select suitable cleaning aids, which are based on
type of cleaning as where applicable. Cleaning aids which are applying must be lint free, non
shredding and non reactive with disinfectant.
6.8 Carry the cleaning activity by moving in order as per flow chart shown mentioned Annexure
no – I and Annexure –II which directs the house keeping personnel to access ( way of entry ) the
area easily.
7.1 Flow chart of house keeping for primary change room, primary corridor , secondary packing
hall & ware house – Annexure-I
7.2 Flow chart of house keeping for primary production area (Oral) & RM ware house
dispensing and sampling area – Annexure-II

7.1 SOP for cleaning of primary production area
7.2 SOP for cleaning of secondary packing hall, ware house and change room
9.0 Distribution
8.2 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, HR.
10.0 History

– – New SOP
Flow chart of house keeping for primary change room, primary corridor, secondary
packing hall & ware house
Annexure-I
Cleaning to be done by Name of the Area Select Cleaning technique whichever

is suitable
Disinfectant Solution Primary Change Room Mopping, scrubbing and

Wiping
Disinfectant Solution Primary Corridor Mopping, scrubbing and

Wiping
Disinfectant Solution Secondary Packing Hall Mopping, scrubbing and

Wiping
Disinfectant Solution Finished Good Ware House Mopping, scrubbing and

Wiping
Disinfectant Solution Raw material ware house Mopping, scrubbing and

Wiping
expect dispensing and sampling area
Note: Disinfectant shall be used by rotating/changing on weakly basis, for preparation of

disinfectant Refer SOP (SOP on Disinfectant usage policy), disinfectants like Savlon 2.5% v/v,
Domex 5% v/v and Lyzol 5%v/v shall be employed for above mentioned areas.
Annexure-II
Flow chart of house keeping for primary production area (Oral) & RM ware house
dispensing and sampling area
Cleaning to be done by Name of the Area Select Cleaning technique whichever

is suitable
Disinfectant Solution Secondary Change Room Mopping, scrubbing and

Wiping
Disinfectant Solution Corridor adjacent to primary packing section Mopping, scrubbing and
Wiping
Disinfectant Solution Strip packing room plus change parts room Mopping, scrubbing and
Wiping
including air lock
Disinfectant Solution Alu-Alu packing room (BQS) plus change Mopping, scrubbing
and Wiping
parts room including air lock
Disinfectant Solution Alu-Alu packing room Mopping,

scrubbing and Wiping
plus change parts room
Disinfectant Solution Main Corridor between capsule filling Mopping, scrubbing

and Wiping
and coating room
Disinfectant Solution Coating room and change parts room Mopping, scrubbing
and Wiping
including air lock
Disinfectant Solution Table inspection room including air lock Mopping,

Disinfectant Solution Compressed tablets quarantine Mopping, scrubbing

and Wiping
including air lock

Disinfectant Solution Compression room including Mopping, scrubbing
and Wiping
compressed tablets quarantine Mopping, scrubbing and Wiping
Disinfectant Solution IP QA Mopping, scrubbing

and Wiping
Disinfectant Solution Tablet punch room & Granules Mopping,

quarantine area
Disinfectant Solution Quarantine room for tablets/capsule Mopping, scrubbing

and Wiping
Disinfectant Solution Capsule filling room including air lock Mopping,

Disinfectant Solution Wet granulation including air lock and Mopping,

dispensed material store room
Disinfectant Solution Dry granulation including air lock and Mopping,

dispensed material store room
Disinfectant Solution RM Ware house sampling area Mopping,

including air lock
Disinfectant Solution RM Ware house dispensing booth Mopping,

and area including air locks
Note: Disinfectant shall be used by rotating/changing on weakly basis, for preparation of

disinfectant Refer SOP (SOP on Disinfectant usage policy), disinfectants like Savlon 2.5% v/v,
Domex 5% v/v and Lyzol 5%v/v shall be employed for above mentioned areas.
SOP On Facility Designing and Qualification
1.0 Objective
To define the Standard Operating Procedure for Facility Designing and Qualification.
2.0 Scope
2.1 This SOP is applicable for pharmaceutical Facilities.
2.1.1 When designing new facility.
2.1.2 Revamping of existing facility.
3.0 Responsibility
3.1 User Department
3.2 Engineering & Utility Department
3.3 Project Department
4.0 Accountability
4.1 Head Projects
4.2 Head QA
consistently.
URS : User Requirement Specification
6.0 Procedure
6.1 Design development of facility shall be carried out prior to construction of the new facility or
revamping of the existing facility and the approach consisting of following steps.
6.1.1 Facility URS
6.1.2 Conceptual study
6.1.3 Preparation and Approval of drawings and specifications
6.1.4 Construction
6.1.5 Facility qualification

6.2 Facility URS is the initial document prepared during the initial stage of the Project.
6.3 Conceptual document is prepared based on the Facility URS, which contains the design
philosophy required to proceed to the next phase of the development.
6.4 Following are the general GMP requirements but not limited to, which shall be built into the
facility during designing
6.4.1 The flow of materials & personal through the building or facilities should be designed to
prevent mix-ups or contamination.
6.4.2 Adequate ventilation, air filtration and exhaust systems should be provided, where
appropriate.
6.4.3 Proper drainage system should be provided.
6.4.4 There should be adequate arrangement for disposal of wastewater and other residues from
the laboratory and production areas.
6.4.5 Quality control and other refreshment areas shall be independent of production area.
6.4.6 Working and in-process space shall be adequate to permit orderly and logical positioning of
equipments.
6.4.7 Pipe-work, electrical fittings, ventilation openings and similar service lines shall be
designed, fixed and constructed to avoid creation of recesses.
6.4.8 Service lines shall preferably be identified by colours and the nature of supply and the
direction of the supply and the direction of the flow shall be marked / indicated.
6.4.9 In the sterile facility,
6.4.9.1 The manufacturing areas shall be clearly separated into support areas (eg: washing &
component preparation areas, storage areas etc.), preparation areas (eg: bulk manufacturing area,
non-aseptic blending areas, etc), change areas, and aseptic areas.
6.4.9.2 Light fittings and air grills shall be flushed with walls and not hanging from the ceiling,
to prevent contamination.
6.4.9.3 There shall not be any sinks and drains in the Grade A & Grade B areas.
6.4.9.4 Doors shall be made of non-shedding materials, preferably of Aluminium or steel

material. Wooden doors shall not be used.
6.4.9.5 Doors shall open towards the high-pressure area so that they close automatically due to
air pressure.
6.4.9.6 Materials transfer between aseptic areas and outside through suitable air locks or pass
boxes.
6.4.9.7 Change rooms should be given appropriate interlocking system, to prevent opening of
more than one door at a time.
6.4.10 The interior surfaces (walls, floor, ceiling) shall be smooth and free from cracks, coved,
permit easy cleaning, painting and disinfections.
6.4.11 Facilities should be designed, constructed, and maintained to prevent entry of insects,
pests, birds, vermins and rodents.
6.4.12 Adequate lighting should be provided in all areas to facilitate proper operations.
6.5 Drawings should be prepared as per the format enclosed.
6.6 Drawings can be taken printout in A4 or in A3 size paper depends on the requirement.
6.7 Drawing format consists of the following
6.7.1 Direction symbol will be at the top left corner if required, which shows all the four
directions East, West, North and South.
6.7.2 Entire drawing shall have a Single line border and drawn to scale.
6.7.3 Legend should be there in all the drawings.
6.7.4 At the bottom right corner, footer is present.
6.7.5 Footer format
6.7.5.1 In the first row of the footer write the Company logo & Name with address.
6.7.5.2 Write the Block name, Floor number and Type of the drawing against the TITLE.
6.7.5.3 Write the No. of the drawing against the DRAWING No.
6.7.5.4 Write the size of scale against the SCALE.
6.7.5.5 Write the sheet number X of Y (X is the sheet number and Y is the total number of
sheets) against SHEET.
6.7.5.6 Write the version number against REVISION.
6.7.5.7 Write the names of the persons against DRAWN BY, REVIEWED BY, and APPROVED
BY.
6.7.5.8 Write the note points against the NOTE.
6.7.6 Any change in the facility should be through change control.
6.8 Procedure for signing the drawings
6.8.1 Person who draws the drawings shall sign against DRAWN BY followed by date.
6.8.2 Person, who signs against REVIEWED BY, should review the drawings with for its
adequacy.
6.8.3 Head Projects and Head QA will sign against APPROVED BY.
6.8.4 Project department approval ensures that the drawing meets the process requirements.
6.8.5 QA approval ensures that the drawing meets the Regulatory and cGMP requirements.
6.9 Based on the drawings and the defined criteria’s, Room Data Sheets are developed.
6.10 For each room, Room Data Sheet Should be prepared as per the Unique Format No.
6.11 The contents of the Room Data Sheets may vary from room to room and those should be
maintained in electronic format.
6.12 Projects & QA department shall approve the Room Data Sheets.
6.13 The construction work starts after the approval of Drawings & the Room Data Sheets
developed.
6.14 Construction
6.14.1 Careful supervision should be done during the construction phase to make sure that all the
design specifications are being met.
6.14.2 After the construction of the new facility or revamping, it should be qualified through
Facility Qualification Protocol.
6.15 Facility Qualification
6.15.1 Facility qualification should be carried out Block wise and also by Room wise.
6.15.2 Facility Qualification Protocol should be prepared Block wise to qualify the facility.
6.15.3 The Facility qualification protocol shall be as detailed as possible to avoid later confusion.
6.15.4 Facility qualification Protocol should be prepared as per the format F02/SOPQA002-00.
6.16 Preparation of Facility Qualification Protocol
6.16.1 Facility Qualification protocol consists of the following and it can be changed as per the
requirement. Facility Qualification Protocol is maintained in electronic format.
6.16.1.1 TABLE OF CONTENTS
6.16.1.1.1 Protocol Approval
Consists of the Name, Designation, Signature and date of the person(s) responsible for the
Preparation, Checking and Approval of the Protocol.
6.16.1.1.2 Objective
The objective of the protocol shall be mentioned in this section.
6.16.1.1.3 Scope
The scope of the subjected facility shall be mentioned in this section
6.16.1.1.4 Execution team
In this section, various responsibilities of different departments involved in the qualification

activities shall be mentioned.
6.16.1.1.5 Facility Description
Brief description of the Facility shall be mentioned.
6.16.1.1.6 Basis of Facility design
The Facility size & other details with reference to user requirement specifications shall be
mentioned.
6.16.1.1.7 Detailed Specifications & Verification of Facility
The facility shall be qualified room wise. Check list is prepared as per the Unique
Format No. from Room Data Sheets and the drawings. Each room is qualified using this
checklist and annexed.
6.15.1.1.8 Summary and conclusion
6.15.1.1.9 Design qualification post approval.
Consists of the Name, Designation, Signature and date of the person(s) responsible for the
Preparation, Checking and Approval of the Protocol.
6.16 Facility Qualification Protocol –Header
6.16.1 Write the number of the protocol against the PROTOCOL NUMBER.
6.16.2 Write the Protocol implementation date against the EFFECTIVE DATE.
6.16.3 Write the name of the block against the BLOCK.
6.16.4 Write module number against the MODULE.
6.16.5 Write the page number against PAGE No. as given below
6.16.5.1 Page X of Y (X is the page number and Y is the total number of pages).
6.16.6 Facility Qualification Protocol Numbering
FQ – FQ for Facility Qualification
/ – Slash
XX – Department Code
/ – Slash
NN – Sequential number
Typical example: FQ/PA/01 is the first Facility Qualification Protocol of Production Block “A”
7.0 Distribution
8.0 History
– – New SOP
SOP on Status Labeling System and Its Control
1.0 Objective: To lay down a procedure for the status labeling system and its control.
2.0 Scope: This Standard Operating Procedure is applicable for identification labels and status
labels used in pharmaceutical company.
3.0 Responsibility
3.1 All concerned department personnel & their HODs are responsible for implementation and
execution of status labeling.
3.2 QA personnel shall responsible for checking, implementation & control of status labeling.
4.0 Accountability
4.1 Department Heads & QA Head shall be accountable for implementation of this SOP.
consistently.
6.0 Procedure
6.1 Label shall be filled by respective person by following SOP on GDP.
6.2 Adequate information shall be filled by respective personnel on labels.
6.3 At the time of use, label shall be filled manually (except labels generating from software) by
using blue ball pen, only QA personnel shall use black ball pen.
6.4 Any information should not be blank.
6.5 Information on label shall be filled as instructed on respective label.
6.6 Doer & checker of concerned activities and department shall signature the label or as directed
on label.
6.7 The labels generating from software shall have a unique format number.
6.8 Contents of Status Label
6.8.1 All labels shall have a unique format no. which shall be written on bottom left side of label
in font size 10.
6.8.2 All status label shall be surrounded by a boarder of ½ pt.

6.8.3 Contents of status label shall differ for all. It shall be depend on activities performed.
6.8.4 Status label shall be color specific as described under individual annexure.
6.8.5 Size of label shall be fixed as per suitability, it is described under individual annexure.
6.8.6 Labels shall be of sticker, card type or generated by computer. Details of the type shall be
described in the respective specimen of the labels.
6.8.7 All label shall have company logo & company name (in font size 12).
6.8.8. Font size shall be fixed as per suitability for all labels, but font type times new roman shall
use for all.
6.8.9 Spacing between contents shall be as per suitability.
6.9 The detail of the in process status labels along with department responsible for handling the
same are given below:-
6.9.1 Quarantine-Under Test
6.9.1.1 After received the consignment from manufacturer/supplier Quarantine under test label
shall be affixed.
6.9.1.2 Specimen copy is attached in Annexure-I.
6.9.2 Sampled Slip
6.9.2.1 After sampling of RM/PM sampled slip shall be affixed.
6.9.2.2 Specimen copy is attached in Annexure-II.
6.9.3 Release Slip (Label for Approval)
6.9.3.1 After analysis of incoming material, if material complies with the respective material
specification, QC shall release the material by affixing release slip label on incoming material.
6.9.3.2 Specimen copy is attached in Annexure-III.
6.9.4 Rejection Slip
6.9.4.1 After analysis of incoming material, if material does not complies with the respective
material specification, QC shall reject the material by affixing rejection slip label on incoming
material.
6.9.4.2 This label be print using ERP on red color sheet.

6.9.4.3 Specimen copy is attached in Annexure –IV.
6.9.5 Dispensed Label
6.9.5.1 The “Dispensed” Label shall be used to indicate that material has been dispensed in
Dispensing Area.
6.9.5.2 Specimen copy is attached in Annexure -V.
6.9.6 Online Rejection
6.9.6.1 During manufacturing process if any material shall reject on line it shall be labelled as
online rejection.
6.9.6.2 Specimen copy is attached in Annexure -VI.
6.9.7 Status Label
6.9.7.1 All the Products lying in the area to be Identify with Status Label indicate the
status of the product.
6.9.7.1 Specimen copy is attached in Annexure -VII.
6.9.8 To be Cleaned Label
6.9.8.1 The “To be cleaned” Label shall be used to indicate that the Equipment is not cleaned
6.9.8.2 Specimen copy is attached in Annexure -8.
6.9.8.3 Note: In an area, if any equipment is not in use although a product is running on other
equipment, in that case after completion of the product/ batch, affix, To Be Cleaned label on both
used and unused equipment’s, previous product will be the product which was last run on that
particular equipment (as per log book). Clean the equipment’s as per next product/ batch, which
is to take under process. After cleaning, replace “To be Cleaned label” with “Cleaned label”.
6.9.9 Cleaned Label
6.9.9.1 The “Cleaned” Label shall be used to indicate that the Equipment is in cleaned condition
and ready for use for the next batch / product.
6.9.9.2 Specimen copy is attached in Annexure -IX.
6.9.10 Container / Bin Status Label
6.9.10.1 All the material / product which shall be store in a container / bin to be identified with
“Container / Bin Status” Label and indicate the details of the material.
6.9.10.2 Specimen copy is attached in Annexure -X.
6.9.10.3 Additional space in bottom in this label is given for affixing label for detailing of the
under test and approval status.
6.9.11 To Be Inspected Label
6.9.11.1 The “To Be Inspected” Label shall be used to indicate that the product is to be inspected
on an Inspection Belt.
6.9.11.2 Specimen copy is attached in Annexure -XI.
6.9.12 Inspected Label
6.9.12.1 The “inspected” Label shall be used to indicate that the product has been inspected and
found as good after the inspection.
6.9.12.1 Specimen copy is attached in Annexure -XII.
6.9.13 Recoverable Rejection Label
6.9.13.1 The “Recoverable Rejection” Label shall be used to indicate that the product rejects at
any stage can be recovered as a product of intended standard after reprocessing.
6.9.13.1 Specimen copy is attached in Annexure -XIII.
6.9.14 Non Recoverable rejection Label
6.9.14.1 The “non-recoverable rejection” Label shall be used to indicate that the product is not to
be added in the next product and subjected for the destruction.
6.9.14.1 Specimen copy is attached in Annexure -XIV.
6.9.15 Loose box Label
6.9.15.1 The “Loose box” Label shall be used for the packed corrugated box containing the
packed finished product which does not contain the standard quantity for a complete corrugated
box.
6.9.15.1 Specimen copy is attached in Annexure- XV.
6.9.16 In Process Under Test Label
6.9.16.1 The “In process under test” Label shall be used to indicate that the In process Product
has been sampled and send to quality control Department for analysis and the release is awaited.
6.9.16.2 Specimen copy is attached in Annexure -XVI.
6.9.17 Under Hold Label
6.9.17.1 The “Under Hold” Label shall be used when some non-conformation or out of
specification finding and not to be taken for further process till proper documentation clearance
for activity is not done.
6.9.17.2 Specimen copy is attached in Annexure -XVII.
6.9.18 In Process Rejected Label
6.9.18.1 The “In Process Rejected” Label shall be used to indicate that the product or material
has been rejected during the operation of any process (such as online rejection for foils) or the
product is rejected during in process (such as in process sample/ in process loss) and not to be
taken for next process and subjected for destruction /return to the vendor/subjected for further
analysis.
6.9.18.2 Specimen copy is attached in Annexure -XVIII.
6.9.19 Under Installation Label
6.9.19.1 The “Under Installation” Label shall be used to indicate that the equipment is under
installation.
6.9.19.1 Specimen copy is attached in Annexure -XIX.
6.9.20 Under Maintenance Label
6.9.20.1 The “Under Maintenance” Label shall be used to indicate that the equipment/ area is
under maintenance.
6.9.20.2 Specimen copy is attached in Annexure -XX.
6.9.21 Approved Label
6.9.21.1 The “Approved” Label shall be used to indicate that the product is released by quality
control department after analysis. After approval product is ready for the release for the next
process.
6.9.21.2 Specimen copy is attached in Annexure -XXI.
6.9.22 Sample For Analysis Label
6.9.22.1 The “Sample for analysis” Label shall be used to store and transfer the sampled
specimen of drug product for analysis.
6.9.22.2 Specimen copy is attached in Annexure-XXII.
6.9.23 Calibration Status Label (For In house & External calibration)
6.9.23.1 The calibration status label shall be used on equipment/instrument which is calibrated
in-house as per given schedule.
6.9.23.1 Specimen copy is attached in Annexure -XXIII.
6.9.23.3 If calibration shall be done by external party than label shall be of their standard, but
label shall have following minimum information but not limited to:
 Equipment/ instrument ID No.

 Calibration date
 Due date of calibration
 Date & Sign. of doer
6.9.24 Scrap Label
6.9.24.1 The “Scrap” Label shall be used to store and transfer the non-recoverable material other
than drug component of product.
6.9.24.2 Specimen copy is attached in Annexure- XXIV.
6.9.25 Equipment Status Label
6.9.25.1 Equipment status label shall be used on equipment to indicate the status of equipment.
6.9.25.2 Specimen copy is attached in Annexure -XXV.
6.9.26 Sampled Slip (Bulk product sampling)
6.9.26.1 After sampling of bulk product sampled slip shall be affixed.
6.9.26.2 Specimen copy is attached in Annexure -XXVI.
6.9.27 Passed Slip (Bulk Product)
6.9.27.1 After sampling of bulk product slip shall be affixed.
6.9.27.2 Specimen copy is attached in Annexure -XXVII.
6.10 Inventory of Status label
6.10.1 Inventory of all status label shall be maintained as per annexure -XXVIII by QA as these
are the formats.
6.11 Issuance of Status label
6.11.1 Issuance of all status label shall be same as format issuance as per SOP on format control.
6.12 Archival of Status label
6.12.1 Archival of filled status label shall be the part of respective batch no. BMR.
6.12.2 When the batch activities shall be completed all the respective status label shall be attach
with BMR.
6.12.3 Labels which shall not be the part of BMR shall be send to QA by respective department
after completion of their valid period.
6.12.4 These labels shall be destroyed by QA as per SOP on destruction.
6.13 Labels printing specification shall be as described in annexures.
6.14 However, the list of labels along with format numbers (updated list) shall be maintained by
QA as per annexure -XXIX. Furthermore the format number for a newly introduced label shall
also be assigned after reviewing the format number list, in order to avoid repetition, and this case
SOP will be revised.
7.1 Quarantine-Under Test – Annexure-I
7.2 Sampled Slip – Annexure-II
7.3 Release Slip – Annexure-III
7.4 Rejection Slip- Annexure-IV
7.5 Dispensed Label – Annexure-V
7.6 Online Rejection – Annexure-VI
7.7 Status Label – Annexure-VII
7.8 To be Cleaned Label – Annexure-VIII
7.9 Cleaned Label – Annexure-IX
7.10 Container / Bin Status Label – Annexure-X
7.11 To Be Inspected Label- Annexure-XI

7.12 Inspected Label – Annexure-XII
7.13 Recoverable Rejection Label – Annexure-XIII
7.14 Non Recoverable rejection Label- Annexure-XIV
7.15 Loose box Label – Annexure-XV
7.16 In Process Under Test Label – Annexure-XVI
7.17 Under Hold Label – Annexure-XVII
7.18 In Process Rejected Label – Annexure-XVIII
7.19 Under Installation Label – Annexure-XIX
7.20 Under Maintenance Label – Annexure-XX
7.21 Approved Label – Annexure-XXI
7.22 Sample For Analysis Label – Annexure-XXII
7.23 Calibration Status Label – Annexure-XXIII
7.24 Scrap Label – Annexure-XXIV
7.25 Equipment Status Label – Annexure-XXIV
7.26 Sampled Slip (Bulk Product Sampling) – Annexure-XXVI
7.27 Passed Slip (Bulk Product) – Annexure-XXVII
7.28 Inventory Control Logbook for Status Labels – Annexure-XXVIII
7.29 List of Status Labels– Annexure-XIX
8.0 Distribution
9.0 History

– – New SOP

Annexure-I
QUARANTINE-UNDER TEST
Company Logo QUARANTINE-UNDER TEST

Material Name __________________________________Date of Receipt____________
GRN No________________________Batch No. ______________Qty.______________
Mfg. Date______________________Exp. Date_______________Container No._______
Mfd. by ____________________________Supplied by___________________________
Sign & Date _____________________________________________________________

Form No.- SOP/QA-000/F01-00
Specification: printing black
Size: 110 x 80mm ± 2mm
Type: Sticker Type
Annexure-II
Sampled Slip
Company Logo SAMPLED SLIP

ITEM:
B.NO.: CONTAINERS:
QUANTITY:
DATE OF RECEIPT: EXP DATE:
SUPPLIED BY:
MFG BY:
GRN NO.
Sampled Qty. Sampled On:
Sampled By: Signature:
Specification: Yellow colour sheet, printing black
Type: Sticker Type

Annexure-III
For Raw Material
Quality Control Department

Company
logo
RELEASE SLIP
Item :
Batch No. : Container No. :
Supplier : Quantity :
Manufacturer : Sampled On :
Q.C.Ref. No. : Exp. Date :
Accepted Qty. : Test Compl. Date. :
Rejected Qty. : Result :
Release Valid Till :
Tested By Signature
Specification: Green colour sheet, printing black
Type: Sticker Type
Annexure-IV
For Raw Material

Company Logo
REJECTION SLIP
Item :
Batch No. : Container No. :
Supplier : Quantity :
Manufacturer : Sampled On :
Q.C.Ref. No. : Exp. Date :
Accepted Qty. : Test Compl. Date :
Rejected Qty. : Result :
Release Valid Till :
Tested By Signature
Specification: Red colour sheet, printing black

Type: Sticker Type
Annexure-V
Dispensed Label
Company Logo Dispensed Label

Material Name /Item Code__________________________________________________
A.R. No._________________________ Batch No.______________________________
Mfg. Date_________________________ Exp. Date_____________________________
For Product _____________________________________________________________
Product Batch No. ________________________________________________________

Gross Weight (Kg.) Tare Weight (Kg.) Net Weight (Kg.)
Dispensed by (Sign / Date) Received by (Sign / Date) Verified by (Sign/Date)
Type: Card Type
Annexure-VI
Online Rejection
Company logo Online Rejection

Material Name
A.R. No.
Product & Batch No.
Qty. Returned
Remarks:
Signature & Date
(Production Officer) (IPQA Officer)
Form No.: SOP/QA-000/F01-00
Specification: Red strip, printing black
Type: Card Type

Annexure-VII
Status Label
Company Logo Status Label

Product Name ___________________________________________________________
Batch No. _____________________________ Batch Size _______________________
Mfg. Date____________________________ Exp. Date__________________________
Stage__________________________________________________________________
Next Stage______________________________________________________________

Checked by (Sign / Date)
Type: Card Type
Annexure-VIII
Company logo To be cleaned

Equipment / Bin / Container ________________________________________________
I.D. No._________________________________________________________________
Previous Product _________________________________________________________
Batch No. _______________________________________________________________

Checked By (Sign / Date/Time)
Specification: Dark Orange, printing black
Type: Card Type
Annexure-IX
Company logo Cleaned
Equipment / Bin / Container ________________________________________________
I.D. No._________________________________________________________________
Previous Product _________________________________________________________
Batch No. _______________________________________________________________
Type of cleaning__________________________________________________________
Done On ____________________________ Use Before _______________________

Done by (sign / date)__________________ Checked by (sign / date/time)___________
Remarks (If any)_________________________________________________________
Checked By IPQA (Sign/Date/Time)_________________________________________

Specification: Green strip, printing black
Type: Card Type
Annexure-X
Company Logo Container/Bin Status

Product Name __________________________________________________________
Batch No.______________________________ Batch Size ______________________
Mfg. Date_____________________________ Exp. Date________________________
Stage__________________________________________________________________
Container / Bin no. ______________________________________________________

Gross weight (kg) Tare weight (kg) Net weight (kg)
Checked by: (sign / date)
Affix Status Label Here

Type: Card Type
Area of bottom empty space: 25 mm
Annexure-XI
Company Logo TO BE INSPECTED

Product Name___________________________________________________________
Batch No.______________________________________________________________
Mfg. Date______________________________________________________________
Container No.___________________________________________________________
Quantity_______________________________________________________________
Checked by (Sign/Date):
Specification: Yellow strip, printing black
Type: Card Type
Annexure-XII
Inspected Label
Company Logo INSPECTED

Product Name___________________________________________________________
Batch No.______________________________________________________________
Mfg. Date______________________________________________________________
Container No.___________________________________________________________
Quantity_______________________________________________________________
Checked by (Sign/Date): Verified by (Sign/Date):
Specification: Green strip, printing black

Type: Card Type
Annexure-XIII
Company Logo Recoverable Rejection

Product Name ___________________________________________________________
Batch No. _________________________________ Batch Size ____________________
Mfg. Date__________________________ Exp. Date____________________________
Quantity _______________________________________________________________
Stage__________________________________________________________________
Checked by(sign / date) Verified by(sign / date)
Specification: Red colour strip, printing black
Type: Card Type
Annexure-XIV
Company Logo Non-Recoverable Rejection

Product Name ___________________________________________________________
Batch No. _________________________________ Batch Size ____________________
Mfg. Date__________________________ Exp. Date____________________________
Quantity _______________________________________________________________
Stage__________________________________________________________________
Checked by(sign / date) Verified by(sign / date)
Specification: Red colour strip, printing black
Type: Card Type
Annexure-XV
Company Logo Loose Box
Product Name ___________________________________________________________
Operator Name __________________________________________________________
Batch No. ________________________________ Batch Size _____________________
Mfg. Date_______________________________ Exp. Date_______________________
Quantity in Box _________________________________________________________

Checked by (Sign / Date) Verified by (Sign/Date)
Type: Sticker Type
Annexure-XVI
Company Logo COMPANY NAME

IN PROCESS UNDER TEST
Stage: Sign/ Date:

Specification: Yellow strip, printing black
Type: Sticker Type
Annexure-XVII
Company Logo Under Hold

Product Name ___________________________________________________________
Batch No. _______________________________________________________________
Stage __________________________________________________________________
Quantity________________________________________________________________
Reason for hold__________________________________________________________
Remark_________________________________________________________________
Hold by (Sign / Date):
Type: Card Type
Annexure-XVIII
Company Logo In Process Rejected

Material name /Item code___________________________________________________
Product Name____________________________________________________________
Batch No.____________________________ Rejected Quantity____________________
Container No._____________________ Stage__________________________________
Reason for Rejection______________________________________________________
Remark ________________________________________________________________
Rejected by (Sign / Date)
Rejected
Specification: Red strip, printing black
Type: Card Type
Annexure-XIX
Company Logo Under Installation

Equipment Name_________________________________________________________
Area ___________________________________________________________________
Checked by (Sign / Date)
Specification: Light purple, printing black
Type: Card Type
Annexure-XX
Company Logo Under Maintenance

Equipment Name/Area_____________________________________________________
ID No.__________________________________________________________________
Location________________________________________________________________
Reason _________________________________________________________________
Checked by (Sign / Date) :
Specification: Brown Strip, printing black
Type: Card Type
Annexure-XXI
Approved Label
COMPANY NAME
Company Logo
Approved
Product Name: Batch No.:
A.R.No.:_________________________________Stage_________________________
Approved by (Sign/ Date) :

Type: Sticker Type

Annexure-XXII
Company Logo Sample for Analysis

Product Name ___________________________________________________________
Batch No._________________________________ Batch Size ____________________
Mfg. Date________________________________ Exp. Date______________________
Sample Qty.______________________________ Stage__________________________
Remark_________________________________________________________________
Sampled by (Sign / Date):
Type: Sticker Type
Annexure-XXIII
Company Logo Calibration Status

Name of Equipment/ Instrument_____________________________________________
ID No.__________________________________________________________________
Calibration Done On ______________________________________________________
Calibration Due on _______________________________________________________
Calibration Done by_______________________________________________________
Status (Complies/not complies) _____________________________________________
Checked by (Sign/ Date)___________________________________________________

Specification: Green Strip, printing black
Type: Card Type

Annexure-XXIV
Company Logo Scrap Label

Material Name __________________________________________Qty.____________
Remark_______________________________________________________________
Checked by (Sign / Date):
Type: Card Type
Annexure-XXIV
Company Logo Equipment Status

Equipment Name ___________________________________ID No._________________
Product Name _____________________________________Batch No._______________
Stage____________________________________________________________________
Checked By (Sign / Date):
Specification: Grey strip, printing black
Type: Card Type
Annexure-XXVI
Sampled Slip (Bulk Product Sampling)

COMPANY
LOGO
SAMPLED SLIP
Item Name : Entry Date :
Batch No. : Batch Qty. :
Mfg. Date : Exp. Date :
Sampled On : Date of Test :
Sampled By : Signature :
Specification: Yellow colour sheet, printing black
Type: Sticker Type
Annexure-XXVII
Passed Slip (Bulk Product)

Company
Logo
RELEASE SLIP
Product Name :
Batch No. : Sampling Date :
Mfg. Date : Batch Quantity :
Test Comply.
Exp. Date : :
Date
Lab. Ref. No. : Accepted Qty. :
Result : Rejected Qty. :
Signature
Tested By :
_______
Specification: Green colour sheet, printing black
Type: Sticker Type
S. Name of Format Date of Quantity Date of Quantity Quantity Issued Received

Remarks
No. Label No. Receiving Received Issuance Issued Balanced by by

Specimen Annexure of Quarantine-Under Test Status Label
Quality Assurance & its Function
 SOP on Guideline for Preparation of Site Master File

 Pharmaceutical Artwork, its Approval, Modification and Implementation
 IN PROCESS QUALITY CONTROL: A REVIEW
 Difference between Quality Assurance & Quality Control
 Quality Assurance & Its Function
QMS (Quality Management System)
 Change control flow diagram…

 Annual Product Quality Review (APQR)
 SOP on Quality Management Review
 Quality By Design and It's Essential Elements
 Difference between Corrective and Preventive Actions……..CAPA
 Validation Master plan—Template for referance
 Overview of Root Cause Analysis Techniques….!!!
 Corrective and Preventive Action
 Differences between FMEA & RCA
GMP Aspect
 Usage of Hose Pipes—Latest approach..!!!

 Gowning Procedure – Entry and Exit Procedure for Control & Critical Rooms of Aseptic
Manufacturing Facility
Regulatory Affairs
 Reasons for FDA violations….

 EU and US agree to share API and drug plant inspection data…!!!
 Regulatory Definitions for "Ambient", "Room Temperature" and "Cold Chain"
 Quality by design approach: Regulatory Aspect………..!!!
 Bioavailability and Bioequivalance the Basic Approach…..
 BIOWAIVER….The Way Forward..
 DMF (Drug Master File)
 Drug Regulatory Agencies across the world
 Regulatory Affairs & its Role in Pharmaceutical
 Effective Dossier Management in Regulatory Affairs
SOPs
 SOP on Password Policy For Computers and Softwares in Pharmaceutical Plant

 SOP on Recruitment of Employees
 SOP on Preventive maintenance of Vibro Sifter
 Handling of Break Down Maintenance
 Calibration of UV-VIS Spectrophotometer
 SOP on Guideline for Preparation of Site Master File
 Recording System for U.V. Lamp burning hours
 SOP on Change Control Management
 SOP for operation , cleaning and maintenance of UV-VIS Spectrophotometer
 Procedure of Operation of Lux Meter and monitoring the Lux level
 Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of Rubber
Stereo
 SOP for DISPOSAL OF WASTE
 SOP for Changeover in Manufacturing and Packing Area
 MOLYBDENUM TEST ……Checking SS grade
 Issue and Usage of Punches and Dies….
 Machine Use Log…
 Operation Of Vibratory Sifter
 Inprocess Checks During Manufacturing…Tablets
 List of QA (Quality Assurance) SOPs
 SOP on Cleaning of Pre-Filters of LAF Unit, Sterile Garment Cubicle, Dynamic Pass
Box
 SOP on Batch Preparation of Vial Filling Process
 SOP For Operation of Carton Coding Machine
 Failure Investigation of Sterility
 SOP on Cleaning and Operation of Vernier Caliper
 SOP on Colour Coding System of Utility Lines
 Operating Procedure of Air Handling Units and Ventilations Units
 Preventive Maintenance of Purified Water (Generation and Distribution) System
 SOP on Issuance, Preparation, Storage, Usage and Disposal of Disinfectant Solution.
 SOP for Assigning of Identification Numbers to Equipments, Sub-Equipments
 SOP for Access Control System, Numbering and Usage
 Sop for Monitoring of Temperature, Relative Humidity and Differential Pressure
 SOP on SOP (Preparation, Approval and Control of Standard Operation Procedure) )
 SOP Format, SOP Template of WHO
SOP on Password Policy For Computers and Softwares in Pharmaceutical

Plant
1.0 PURPOSE:
The purpose of the document is to establish a procedure for allocation, maintenance of

uniqueness; and confidentiality of passwords which in turn useful in achieving the maintenance
of authenticity, integrity, confidentiality and security if electronic data.
2.0 SCOPE:
It is applicable to all computers, software’s, PLCs and any other electronic devices used in the
QA, Warehouse, Quality Control, Production and Utilities for generating data records except for
the software used for the purpose of the management of the inventory control.
3.0 RESPONSIBILITY:
 Head of Production:
 Head of Engineering
 Head of Quality Control
 Head of Quality Assurance
4.0 DEFINITION:
 Password: A series of character that enables someone to access a file, computer or

program and prevent unauthorized access.
 Administrator: Person will have full access to the system.
 Supervisor: Person who will have access to change the daily operational variables,
which are required to identify operations from each other, e.g. Batch No. / Lot No.
Operator Name.
 Operator/ User: An individual who can only operate the system.
5.0 PROCEDURE:
5.1 All computers, software’s, PLCs and any other electronic devices used in the Warehouse,
QA, Quality Control, Production and Utilities for generating data records shall have restricted
access through user passwords.
5.2 The Quality Assurance shall assign individual passwords to log into the system and access
the system.
5.3 The password shall be categorized on the basis of access rights assigned and /or design of the
system.
5.4 The password preferably shall be allocated at Administrative level, Supervisory level and
User level depending upon the availability of the provision in the system and the equipment.
5.5 The individual shall maintain the confidentiality of passwords assigned to him/her.
5.6 The assigned user passwords shall be enabled in the system.
5.7 Following category of the passwords are forbidden for use:
5.7.1 First Name
5.7.2 Surname
5.7.3 Birth Date
5.7.4 Telephone Numbers
5.7.5 Name of cities
5.8 The password allocated shall be recorded in the Annexure-I and maintain it under lock and
key in Quality Assurance department.
5.9 The data / records on electronic system shall be viewed in case of emergency or during
inspection / audit by another person only after approval from Quality Assurance.
5.10 The uniqueness of the passwords shall be maintained such that no two individuals shall
have the same passwords for the same system.
Note: Same password can be shared by the different user level individuals in case if there is no
provision for generating more than two passwords for the system at User level.
5.11 The passwords shall be revised on quarterly basis and records of the same shall be
maintained under lock and key in Quality Assurance department.
5.12 Once the revised password is enabled, previous password record shall be made obsolete and
destroyed on yearly basis.
5.13 Quality Assurance department shall verify randomly that old password does not permit
access to the system.
5.14 No password shall be repeated for that year for any systems.
5.15 The access rights shall be defined by Quality Assurance department and shall be recorded in
the Annexure -II
5.16 In case of any individual who leaves the organization in between to whom the password has
been already issued, the same password shall not be issued to the newly joined replacement for
that post. Instead new password shall be issued to the new recruit and record of the same is
maintained.
6.0 REFERENCES:
SOP on Design and Control of Documents
7.0 ENCLOSURES:
7.1 Password Allocation Record : Annexure-I
7.2 Access Rights Record : Annexure-II
8.0 ABBREVIATIONS :
QAP : Quality Assurance Procedure
PLC : Programmable logic control

ID : Identity
Annexure-I
PASSWORD ALLOCATION RECORDS
Name of
Equip./ System ID No.
Equipments/System
Minimum Characters
Location
Required for Password
Security Level
Administrative/Supervisory/User
Available
Password Allocation Details:
Administrator
Password
Password
Name of Candidate Designation User ID Password Allocated
Expiry
By(Sign/Date)
Supervisor
Password
Password
Expiry
By(Sign/Date)
User
Password
Password
Expiry
By(Sign/Date)
Note: QA Department shall assign the password and fill in details in page 1of 2 of form. The
password shall be communicated to concerned personnel and sign of password shall be taken on
page 2 of 2 (Page 1 of 2 shall be kept confidential).
Annexure-II
ACKNOWLEDGEMENT OF PASSWORD ALLOCATION
Acknowledgement of Password
Administrator
Name of Candidate Password Expiry Date Sign. of Password Holder
Supervisor
User
RIGHTS ALLOCATION RECORDS
Name of
Equip. ID. No.
Equipments/System
Location Function of Equipment
Security Level
Administrative/Supervisory/User
Available
Criticality of activity to be Carried out at system:
Rights Allocation
Approved By Authorized By
Security Level Rights Assigned
(Head QA) (Unit Head)

Administrator

Supervisor

User
SOP on Recruitment of Employees
1.0 Objective
To lay down a procedure for Recruitment of Employees.
2.0 Scope
This procedure shall apply to Human Resource Department of pharmaceutical Industry.
3.0 Responsibility
3.1 Microbiologist shall responsible to follow the procedure mention in this SOP.
3.2 Head of Human Resource Department & QA Head shall be responsible for compliance of the
procedure.
4.0 Accountability
4.1 Head of Human Recourse Department & QA Head shall be accountable for implementation
of this SOP.
GMP : Good Manufacturing Practice
GLP : Good Laboratory Practice
HRD : Human Recourse Department
6.0 Procedure
6.1.1 At the time of recruiting any employee his qualification and experience in the job for which
he is to be appointed shall be taken into consideration by the Human Resource Department.
6.1.2 Copies of the certificates of qualification and experience produced by the employee shall
be kept as office record.
6.1.3 At the time of appointment of any employee he shall be directed to get himself medically
examined by the Doctor approved by the company for this purpose.
6.1.4 Only if the employee is declared by the Doctor medically fit to carry out the job for which
he is appointed, then the employee shall be allowed to serve the company. The original medical
certificate produced by the employee shall be kept as office record.
6.1.5 The employee shall be issued a specific Appointment Code Number.
6.1.6 The employee shall also be issued a specific Swipe card for recording his attendance by the
swipe card sensor machine at the start and at the end of the work by the employee in the
manufacturing unit.
6.1.7 Every staff employee shall be provided with an appointment letter bearing his signature and
that of the appointing authority of the company.
6.1.8 Every staff employees shall be served with a job description document indicating his job
responsibilities during his stay with the company. This document shall be signed by the
employee, Director or head of the Department and HRD manager.
6.1.9 All employees, including temporary employees, shall be given GMP training in the start of
their service and periodically thereafter during their stay with the company as per SOP titled
“For training of personnel”. This training shall be evaluated through Questionnaire.
6.1.10 Every staff employee shall be supplied with the handbook of company information,
Quality policy and objective and Literature describing GMP. He shall be periodically given the
following trainings every year during his stay with the company, in addition to the Induction
Training given at the time of his appointment:
i) SOP Training
ii) On-Job Training
iii) GMP Training
iv) Industrial safety & Security Training
v) GLP Training for the staff working in Laboratory
vi) Need based Trainings when anyone requires
6.1.11 The training mentioned at S.No. i) To v) above shall be evaluated through Questionnaire
and records shall be maintained as per SOP titled “For Training of Personnel” by the Q.A.
Department.
6.1.12 It shall be the duty of every employee to intimate to his supervisory about his illness or
abnormal health or open lesions which shall adversely affect the quality of the products.
6.1.13 It shall be the responsibility of the supervisor to disallow any employee who is unfit to
perform his job responsibility due to apparent illness or open lesions on his body which are likely
to affect the quality of the products and shall not be allowed to handle starting materials,
packing materials, in-process materials and drug products until his condition is no longer judged
to be a risk.
6.1.14 All the employees shall avoid direct contact of raw materials, intermediates, finished
products and un-packed products with unprotected hands.
6.1.15 Prior to employment all personnel shall undergo medical examination, including eye
examination, freedom from tuberculosis, skin and other communicable or contagious diseases.
Thereafter, they shall be medically examined periodically, at least once a year and necessary
records shall be maintained by the Human Resource Development.
6.1.16 All the employees, prior to and during employment, shall be imparted training to ensure
personnel hygiene. A high level personal hygiene shall be observed by the employees engaged in
the manufacturing processes.
6.1.17 All the employees shall wear clean body coverings appropriate to their duties.
6.1.18 It is mandatory for all the employees to observe dress code and wear uniform provided by
the company.
6.1.19 Smoking, eating, drinking, chewing or keeping food, drink and personal medicine shall
not be permitted in production, laboratory, storage and other areas where they might adversely
influence the product quality.
6.1.20 Casual workers or Permanent workers engaged by the company to carry out the work of
loading and unloading of materials shall not be allowed to enter and work in the production area.
6.1.21 The employees working in the maintenance department shall not enter the production area
without wearing proper uniform.
6.1.22 Every employee shall be bound to follow the Company Policy and Rules & Regulations.
Not Applicable
8.0 Distribution
Controlled copies- Production, Human Resource Development
9.0 History
– 00 New SOP
SOP on Preventive maintenance of Vibro Sifter
1.0 Objective:
To lay down a procedure for Preventive Maintenance of Vibro sifter.
2.0 Scope:
This SOP is applicable for the preventive maintenance of Vibro sifter to pharmaceutical
formulation plant.
3.0 Responsibility:
3.1 Technician/above –Engg. Is responsible for Preventive Maintenance of Vibro sifter
4.0 Accountability:
4.1 Head- Engg. Shall be accountable for implementation and compliance of this SOP
5.0 Abbreviation
Not Applicable
6.0 Procedure:
6.1 Monthly:
6.1.1 Before carried out the preventive maintenance Switch off the incoming supply and display
UNDER PREVENTIVE MAINTENANCE.
6.1.2 Check rugged spring for proper tight ness, rectify if any abnormality.
6.1.3 Check dead weight for proper fitting.
6.1.4 Lubricate the motor bearings.
6.1.5 Check wheels for free movement and it should lock proper if any abnormalities rectify it.
6.1.6 Check motor electrical terminals for proper tightness.
6.1.7 Check all gaskets for any damage, replace if required.
6.1.8 Check operation sifter for proper vibration if less vibration adjust the dead weight.
6.1.9 Record the details in attached annexure no.-I
7.0 List of Annexure / Format
7.1 Check list for Preventive maintenance of Vibro Sifter – I
8.0 References
8.1 SOP on SOPs.

8.2 Operating manual
9.0 History
– 00 New SOP
Annexure-I
Preventive Maintenance Record of Vibro sifter.
ID No. OF Equipment:
Capacity:
Area:
Frequency: Monthly.
Date:
Sr.
CHECK POINTS STATUS
No.
Check rugged spring for proper tightness, rectify if any
01
abnormality.
02
Check dead weight for proper fitting.

03 Lubricate the motor bearings.

Check wheels for free movement and it should lock proper if
04
any abnormalities rectify it.

05 Check motor electrical terminals for proper tightness.
06 Check all gaskets for any damage, replace if required.
07 Check operation sifter for proper vibration if less vibration

adjust the dead weight.

Done By: Checked By
Handling of Break Down Maintenance
Objective
To define a procedure for Handling of Break Down Maintenance.
Scope
This SOP is applicable for break down of any equipment.
Responsibilities
 Engineering personnel will attend the break down maintenance.

 Engineering Supervisor/technician will maintained the document
 Concern department personnel will check the machine equipment after completion the
breakdown maintenance.
Procedure
 Any breakdown in the equipment the, concerned department will inform the engineering
dept. through as by filing a requisition in which a detail shall be mentioned
 Head engineering shall depute their personnel to that concerned place.
 Engineering staff shall take permission from the concern dept. before starting
the maintenance.
 Before starting the work “UNDER MAINTENANCE” tag should be hanged on the m/c
when it is in breakdown.
 Engineering staff will rectify the defect and in case if external source is required then the
same should be communicated.
 If rectification / servicing is done by an external agency, the concerned engineer of
section will check and certify that the job has been done properly.
 If during maintenance any part of the equipment is found damaged/deteriorated the same
should be replaced and should be reflected in equipment history card.
 After completion of break down maintenance concern department supervisor will check
the Equipment for smooth operation.
 After completion of break down maintenance concern department supervisor will update
the equipment history card for concern equipment or machine.
 Satisfaction regarding break down handling shall be given in same requisition by doing
signature of related department.
Calibration of UV-VIS Spectrophotometer
1.0 Objective
To lay down the procedure for calibration of UV-VIS Spectrophotometer
2.0 Scope
This procedure is applicable for the Calibration of UV-VIS spectrophotometer.
3.0 Responsibilities
QC officer/ Executive : Responsible for the calibration and to review the results of calibration of
the instrument.
QC Head/ Manager : Responsible for accountability and effective implementation of the standard
procedure for operation of instrument.
4.0 Procedure
4.1 Calibration of instrument is important as :
 It performs the regular performance checks.

 It ensures that the testing performed on the respective instrument give the accurate
results and meets the standards of GMP and GLP.
4.2 Use the reference standards for calibration along with their certificates.
4.3 Calibration shall be done as follows:
4.3.1 Control of Wavelength:
 Chemicals required: 1.4 M perchloric acid, Holmium perchlorate solution.
1. Preparation of 1 .4 M Perchloric acid preparation : Dilute 11.5 ml of Perchloric acid

(70%) to 100 ml with water.
2. Preparation of Holmium Perchlorate solution:Dissolve about 1.0 gm of Holmium
oxide in 1.4 M Perchloric acid with the aid of heating on a water bath, cool and dilute to
25 ml with same solvent
 Record the spectrum of Holmium perchlorate solution from 200nm to 600nm using 1.4M
Perchloric acid as reference solution.
 Note down the maxima observed at wavelength against the acceptance criteria
given below:
Wavelength Maximum Tolerance
241.15 nm 240.15 nm to 242.15 nm
287.15 nm 286.15 nm to 288.15 nm
361.50 nm 360.50 nm to 362.50 nm
536.30 nm 533.30 nm to 539.50 nm
4.3.2 Control of Absorbance:
 Chemicals required : .005M sulphuric acid, Potassium dichromate primary standard.
For Ultra violet region:
1. Dilute 0.6 ml of Sulphuric acid to 2000 ml with purified water (0.005 M Sulphuric acid).
2. Weigh accurately 57.0 to 63.0 mg of Potassium dichromate primary standard (previously
dried at 130°C for constant weight) and transfer it to 1000 ml volumetric flask. Dissolve
in 0.005M sulphuric acid and make up to the mark with the same acid.
 Measure the absorbance at 235nm, 257nm, 313nm and 350nm using 0.005M sulphuric
acid as reference solution.
For visible region:
1. Weigh accurately 57.0 to 63.0 mg of Potassium dichromate primary Standard (previously

dried at 130°C for constant weight) and transfer it to 100 ml volumetric flask.
2. Dissolve in 0.005M sulphuric acid and make up to the mark with the same acid.
 Measure the absorbance at 430nm using sulphuric acid as reference solution.

 Calculate the value of A(1% , 1 cm ) using the expression given below :
A (1%, 1 cm) = Absorbance x 1000 / wt. in g x 100
 Check the value of A (1%, 1 cm ) at each wavelength against the acceptance criteria

given below :
Wavelength Maximum Tolerance
235 nm 122.9 nm to 126.2 nm
257 nm 142.8 nm to 146.2 nm
313 nm 47.0 nm to 50.3 nm
350 nm 105.6 nm to 109.0 nm
430 nm 15.7nm to 16.1nm
4.3.3 Limit of stray light:
 Prepare a solution of 1.2 % w/v g of Potassium chloride (previously dried at 105°C, 2

hours) Purified water.
 Determine the absorbance using path length of 1 cm at 200 nm against purified water as
blank.
 Acceptance criteria : Absorbance at 200 nm should be greater than 2.0
4.3.4 Resolution power:
 Prepare a solution of 0.02 % v/v Toluene in Hexane as follows:

 Dilute 2.0 ml of toluene to 100.0 ml with hexane. Further dilute 1.0 ml this solution
to 100.0 ml with hexane.
 Record the spectrum of 0.02% v/v solution of toluene in hexane from wavelength 250nm
to the wavelength 300 nm.
 Record the absorbance at the maxima at about 269 nm and minima at about 266
 Calculate the ratio of absorbance by dividing the absorbance at the maxima at about
269nm and minima at about 266nm
 Acceptance criteria : The ratio of Absorbance at the maxima at about 269 nm to
that at the minimum at about 266 nm is not less than 1.5.
5.0 ABBREVIATIONS:
UV-VIS : Ultra violet visible
QC : Quality Contro
GMP : Good manufacturing practices
GLP : Good laboratory practices

nm : Nanometer
SOP on Guideline for Preparation of Site Master File
Objective
To write a guideline for preparing Site master File (SMF).
Scope
This Sop is applicable for preparation of Site master file.
Responsibility
QA Personnel
Head QA,
Procedure
Site Master File (SMF) is a written document, which provide the authenticate information about
a manufacturing facility for whom it has prepared and concerned.
Site Master File shall have a unique document no. Format of Site master file shall fix when first
time prepared.
SMF Preparation and Approval: SMF shall initiate from project and finalized after completion
of facility and startup of work it shall finalize. The SMF shall be prepared by QA personnel,
checked by Plant head and approved by QA Head.
The contents of SMF shall be as under : It includes following headings and then details
under these:
 General Information
 Personnel
 Premises and Equipment
 Documentation
 Production
 Quality Control
 Contract manufacture and analysis
 Distribution, complaints and product recalls
 Self Inspection
GENERAL INFORMATION: General information section of SMF shall include the brief
information and description of the firm. Name and address of the site including the telephone,
fax and electronic mail shall be mentioned. Quality Policy of the company and the quality
management system shall be described.
Description of the firm shall detail with location and surroundings. The drugs which are
manufacturing at the site.
PERSONNEL: A list of key personnel including their responsibilities, qualification and

experience should be mentioned. Medical checkup and it schedule for personnel working in
manufacturing core areas should be described.
Gowning procedure with their maintenance shall be described.
Training of personnel including from starting to continuity like Induction, cGMP, job-specific
and external training shall be covered. Evaluation method of training is must to explain.
PREMISES AND EQUIPMENT: Entire details of Premises with MOC shall be explained by
highlighting the areas (like manufacturing, eng., QA & QC etc.) in the layouts. A brief
description of equipments and laboratory instruments shall be described including their details as
annexure.
Preventive maintenance and Sanitization and Pest Control measures shall be included in the Site
Master file.
All utilities like water, HVAC, compressed air, nitrogen gas facility including steam generator,
chiller, and boiler shall describe with their capacity and for the HVAC & water system all related
layouts shall explained. Any special areas for handling of highly toxic hazardous and sensitizing
material should be clearly addressed.
DOCUMENTATION: This section shall detail the description of documentation & data control
system. Documents related to product quality like Specifications, STPs other documented
procedures shall be described under this section.
PRODUCTION: Flow charts of all drug manufacturing procedures shall elaborated with their
Production process controls should be described. Ma & Material handling, movement during
manufacturing process shall be written. Document should detail the arrangements for handling of
rejected materials and finished products.
QUALITY CONTROL: Description of QC activities shall be detailed which shall include the
preparation, revision and distribution of specifications, STPs, GTPs. Procedure & responsibility
for review and release of batch. Handling of Out of Specification policy should be defined under
this section.
CONTRACT MANUFACTURE AND ANALYSIS: Details of contract agreement which

states the policies regarding the supply of materials, testing, manufacturing process controls,
packaging and final dispatch of the product shall de detailed.
DISTRIBUTION COMPLAINTS AND PRODUCT RECALL: Distribution, product recall
and handling of market complaint policy and procedure to be mentioned here by given cross
reference of SOP.
SELF INSPECTION: A self inspection schedule with procedure shall describe in this section.
Wherever applicable a cross reference of Sops shall be given in SMF. As attachments of SMF
shall be Layouts, list of key personnel’s, equipment/instrument /utilities list, manufacturing
procedure flow charts, AHUs & water system’s layouts, site plan, civil layouts by highlighting
areas, SOPs list, organograms and whatever required shall attached as per SMF annexure.
Review and Up-dation of SMF: All changes has been done, shall updated in SMF after a
frequent interval or change record shall be tentatively maintained and at the time of revision all
change shall be incorporated.
Review period shall be two years. After revision, document revision no. shall be revised.
SOP on Change Control Management
Objective
To write a procedure for change control management
Scope
All the changes in documents, facility, equipment, system etc.
Responsibility
Head QA,
Head production
Plant head
Procedure
Change control: Change control is a quality tool and a management to maintain and keep the
records of all changes as a history. Changes can be related to facility, documentation, system,
equipment, instrument, procedure, layouts and products etc.
Category of changes
Changes can be categorized into three types:-
1. Minor
2. Major
3. Critical
 Minor change: A change that may not have an impact upon the identity, quality, purity,
strength, stability, safety and efficacy or physical characteristic of the product.
 Major change: A change that may have an impact upon the identity, quality, purity,
strength, stability, safety and efficacy or physical characteristic of the product.
 Critical change: A change that has a significant impact on quality and /or safety of the
final product.
Initiation of change control
 Change control should always initiated by user, with whom changes are related. Before
initiating the changes an initiating form shall be issued by QA on intimation, in this
initiating form all change details shall be detailed.
 Initiation form when filled, send to HOD, HOD shall check whether changes is to be
done or related documents and system are adequate.
 After approval from HOD, Change initiation form shall send to QA for its approval. QA
shall read and study the all, and fix either changes to be done or not.
 After decision, QA shall categorize the changes and approval shall be as per category.
Numbering system for changes
1. All changes shall be numbered as a specific numbering system, as example it shall be

CC/XXX/YYYY demonstrated as: CC denotes to change control, XXX denotes to
sequential number and YYYY denotes to year,
2. E.G. CC/001/2017: this shall be the first change control in year 2017.
Approval and review of change control
 After approval on change initiation form user shall give the intimation for change control
form, QA issued the form by assigning change control number.
 User shall fill the form and make available all documents related to proposed changes; all
attachments shall flow with the form to HOD than QA.
 QA head review the form, as per assigned category, review all attached documents and
planned programmes related to changes.
 After a successful review QA shall approve the form. This shall be entered in log book of
change control by QA personnel.
 In case change control related to regulatory shall be approved by regulatory in
consultation with Head QA.
Evaluation and implementation
 Head QA shall assign the effective date of implementation of the changes and the
originating department shall plan for any necessary training and shall update the relevant
documents with corrective actions jointly with QA. The status of completion of action
shall be mentioned in the change control form by the originating department and shall be
forwarded to QA.
 Implemented change control shall be further reviewed by Head QA. After finding all
correct the documents undergoing for changes / revisions shall have revised as per the
procedure.
 Duly approved and closed change control forms are then filed and maintained by QA.
Closing of Change control
Change control must be close within a specified period in exceeding a proper justification to be
done.
Sample Annexure
1. Log book change control
Change Category of CC Closed

Originating Proposed QA Effective Date of
control change Approved / on: (QA)
Department Change Sign/Date Implementation
No. control Rejected sign/Date
2. Sample- Change initiation form
Change originated By: Date:

Proposed Change details:
Raised by (Sign & Date):
Comments from HOD:
HOD sign. (Sign & Date):
QA Head comments:
Category assigned Critical Major Minor
Head QA (Sign & Date):
3. Change control form
Change Control Number Date

Category of Minor/Major/Critical
Changes
Issued By
Originating Department
Originator’s (Sign &
Date)
Existing (if necessary, attach details):
Proposed Change (if necessary, attach details):
Change affecting (Tick the appropriate √): Equipment/Instruments/ Process Controls/ Facility/ PM
/ Documents / RM / batch / Product /Utility/regulatory. In case other ______________
Justification for Change (if necessary, attach details):

HOD Comment ( sign & Date):
Approval
Evaluation by QA: QA Head (sign & date):
Date of implementation:
In case of regulatory (forward to regulatory) Head regulatory (sign & date)
Post implementation comments by QA Sign & Date
Closed by –QA head Sign & date
Related articles:
Change control PPT:-http://pharmapathway.com/blog/change-control/
Change control flow diagram:-http://pharmapathway.com/blog/change-control-flow-diagram/
Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of

Rubber Stereo
1.0 Objective
To lay down a procedure for Inventory, Storage, Issuance, Withdrawal, Destruction and
Reconciliation of Rubber stereos used on packing / overprinting machines.
2.0 Scope
This SOP is applicable for placing order, receiving, checking of impression, issuance, usage,
withdrawal and destruction of rubber stereos used for all packing / overprinting machines at
pharmaceutical formulation plant.
3.0 Responsibility
Production Operator/ Technician/Printing In-charge shall be responsible for follow the procedure
mention in the SOP.
Production Officer/ above shall ensure the proper usage, withdrawal and destruction of rubber
stereos used on all packing/ overprinting machines.
Head & QA Personnel shall be responsible for proper compliance of SOP.
4.0 Accountability
Department Head and QA Head shall be accountable for implementation of this SOP.
6.0 Procedure
6.1 Order, Receipt & Issuance of Stereos
6.1.1 As per the production planning the order of the required stereos should be placed to the
party by Printing In-charge duly checked by the Production Officer and verified by QA
Personnel as per Annexure-I. The details shall be overprinted with the proper instructions
regarding the type of stereos, stereo size and the quantity shall be mentioned with instructions.
6.1.2 Every stereo record shall have a serial number as described below:
MMM/XXX/YY, where, MMM means first three letters of the current month e.g. Sep for
September, XXX means serial number e.g., 001,002,003 and so on…, and YY means last two
digits of the current year e.g., for 2017 it would be 17 and so on….
6.1.3 Number of stereo shall be ordered as per printing requirement and quantity shall be
mentioned in Annexure-III.
6.1.4 After receiving the stereos, printing In-charge personnel shall check whether these are as
per Stereo Order and shall check the delivery challan.
6.1.5 Printing Operator shall take the stereo impression which shall be checked by printing In-
charge and counter checked by production and further verified by QA as per Annexure-II.
6.1.6 If impression of stereo is not clear or any type of discrepancy observed then respective
stereo shall be destroyed by responsible Production Personnel in presence of QA personnel.
6.1.7 Impression of next stereo shall be taken as per Annexure-II. Previous impression shall be
diagonally cut and signed by printing In-charge.
6.1.8 If rejection of impression shall repeat then step no. 6.1.6 and 6.1.7 shall be followed.
6.1.9 After completion of impression printing In-charge shall handover the stereos to Production
Department. Production personnel shall enter the details in Annexure-III.
6.1.10 Production personnel shall kept the stereos in designated area under lock & key.
6.2 Issuance of Stereos:
6.2.1 In case of printing of outer carton, inner carton and label stereo shall be issued to printing
In-charge by responsible production personnel in presence of QA personnel as per Annexure-III.
6.2.2 In case of foil stereo shall be issued to individual section head by responsible production
personnel in presence of QA personnel as per Annexure-III.
6.3 Usages of Stereos:
6.3.1 After setting standard number of stereos on the packing / overprinting machine, the
operator shall give the impression of the stereos on foil / cartons / label etc. for checking by the
Production and verified by QA Personnel. (In case of carton / label Printing In-charge and
Quality Control Personnel shall also check the impression).
6.3.2 After verifying the impressions, sample of verified impressions duly signed by concerned
personnel shall be attached as specimen to the BMR. This specimen is known as ‘Initial Proof’.
6.3.3 After verification processing of batch shall be started.
6.3.4 During the batch run, if any stereo or full set of stereos shall change, then shall be followed
by step no. 6.3.1 to 6.3.2.
6.3.5 After completion of the batch, the operator shall take the impression of the stereos on foil /
cartons / label. These impression shall be verified by Production Personnel and counter checked
by QA Personnel. This is kept in the BMR as the ‘Final Proof.
6.3.6 After verification of the completed batch, all the used stereos shall be handed over to the
responsible Production Personnel.
6.4 Withdrawal of Stereos:
6.4.1 If the batch is suspended half way, the final specimen of the impression shall be maintained
with BMR and stereo shall be handed over to responsible production personnel before packing of
the next batch. Preserve the stereos of suspended batch in lock & key and subsequently shall be
re-issued from responsible production personnel as per Annexure-III, when remaining quantity
of suspended batch is to be packed.
6.4.2 Take the line clearance from QA Personnel before packing of remaining quantity of
suspended batch.
6.4.3 Production Officer shall check the initial proof of stereo impression and counter checked
by QA Personnel before starting the packing of remaining quantity of suspended batch.
6.4.4 Meanwhile coding/ printing if the stereo get smudge or damage the same shall be replaced
by reissuing new one and the proof shall be again checked by Production and QA personnel.
Record the re-issuance in the Annexure-III.
6.4.5 Stereo shall be withdrawal after cleaning by using thinner.
6.4.6 The exact number of stereos shall be returned by operator/ Printing In-charge and
withdrawal by production personnel as per Annexure-III.
6.4.7 Withdrawal of stereo shall be done in presence of QA personnel.
6.5 Destruction of Stereos:
6.5.1 Ensure that after the usage of the stereos of previous batch / product are removed and hand
over to Production personnel in presence of QA personnel as per Annexure-III.
6.5.2 Production Personnel shall destroy the used stereos in presence of QA personnel. by cutting
them into pieces across the letters using scissor and disposed off the destructed stereo to scrap
room in polythene bag.
6.5.3 Destruction details shall be recorded in Annexure-III.
Stereo Order – Annexure-I
Stereo Checking Record – Annexure-II
Stereo Reconciliation Record – Annexure-III
8.0 Distribution
Controlled copies- Quality Assurance, Production & Quality Control
9.0 History
– – New SOP
Annexure-I
Stereo Order
Sr. No._________ Date: ______________
To,
______________________
Product Name:- _______________________________ B.

No.:_____________________
Type of Stereo for Foil: – Flat / Grooved
Stereo Size:-
Qty. Required:-
Type of Stereo for carton / Others (Specify)………………….: – Flat
Stereo Size:-
Qty. Required:-
Stereo Detail for Foil:-
Stereo Detail for Carton / Others (Specify)………………………:–

Prepared By Checked By Verified By
(Printing In-charge) (Production) (QA)
Annexure-II
Stereo Checking Record
Date
Product Name B. No.
Batch Size Mfg. Date
Exp. Date M.R.P.
Impression of Stereos:
Done By Checked By Counter Checked By Verified By
(Operator) (Printing In-Charge) (Production) (QA)
Annexure-III
Stereo Reconciliation Record

SOP For Operation of Carton Coding Machine
1.0 Objective:
To lay down a procedure for operation of carton coding machine.
2.0 Scope:
This SOP is applicable for operation of carton coding machine.
3.0 Responsibility:
Officers or above – Production.
4.0 Accountability:
Production Head.
5.0 Abbreviations
SOP : Standard Operating Procedure.
No.: Number
Date : Manufacturing Date
Date : Expiry Date
MRP : Maximum Retail Price
BPR : Batch Processing Record
6.0 Procedure:
6.1 Pre-start-up:
Check the status of the machine for its operation.
Visually check the machine and surrounding area for cleanliness.
Visually ensure that there are no remnants of the previous Batch / day operation.
Take the line clearance from In-process quality assurance officer before starting the coding
operation and enter the line in Batch Production Record.
Write the Batch No. Product Name, Date and Signature on the machine status tag.
Get the coding details such as Batch No., Mfg. Date, Exp. Date & MRP of vial from production
officer.
Get the rubber stereos from the production officers and enter in the batch production record and
set the rubber stereos on the stereo master.
Take the unit cartons already issued from production officer as per the secondary packing
material requisition from store.
6.2 Start up:
Note: Batch coding to be performed in a separate coding room with limited access of only
acoding operator and production officer.
Ensure that one coding operation of product is carried out at one time.
Switch ”ON” the machine from main panel.
Switch on the machine and adjust the coding materials for alignment of impression.
Fix the rubber stereos on coding muster.
Put ink on ink roller and run machine till ink spread uniformly.
Get the first coded material Approved by In-process quality assurance officers and specimen
sample attached in batch production record.
6.3 Operation:
Start coding operation only after getting Approval from In-process quality assurance officer.
Store the coded material in plastic crates put status tag, store the crates under lock and key in
storage rack after completion of days work.
Collect and count the rejected coded materials in poly bags and do the entries in Batch
Production Record.
Get the last coded material approved by In-process quality assurance officer and attached in
batch production record.
Record the operation time in equipment log book as per SOP
6.4 Shut down:
After completion of the Batch, rubber stereos to be destroyed as per SOP and Enter in Batch
Production Record.
After completion of the operation switch off the coding machine.
Remove the coded /encoded cartons from the machine and store under lock and key.
Collect and count the rejected unit cartons from the machine and kept in polybags and enter the
quantity in BPR.
Destroy and dispose off the collected unit cartons.
Switch off the main electric supply. Record the operation, cleaning & Maintenance details in the
equipment log book as per SOP and get checked by production officer.
Not Applicable
8.0 Distribution
Controlled copies- Quality Assurance, Production, Quality Control
9.0 History
Date Revision Number

Reason for Revision
– 00 New SOP
SOP on Cleaning and Operation of Vernier Caliper

1.0 Objective
To lay down the procedure for Cleaning and Operation of Vernier Caliper.
2.0Scope
This standard operating procedure is applicable for formulation plant of Pharmaceutical

company name with location.
Make: Mitutoyo.
3.0 Responsibility
Trained worker / Operator shall be responsible for cleaning and operating the equipment as per
this SOP.
Production Supervisor / Officer shall be responsible for implementation of this SOP.
Head-Production / designee shall be responsible for compliance of this SOP.
I.D.- Inner Diameter
O.D.- Outer Diameter
mm – millimeter
SOP – Standard Operating Procedure
QA – Quality Assurance
5.0 Procedure
5.1 Measurement of O.D.
5.1.1 Switch ‘on’ the Vernier Caliper.
5.1.2 By pressing zero key, 0.00 shall be displayed on the screen.
5.1.3 By pressing inch /mm key, the display shows reading in inches / mm.
5.1.4 Place the tablet in between the lower jaws of Vernier Caliper by rotating the adjustment
screw. Make sure jaws shall just touch object to be measured.
5.1.5 Outer diameter shall be displayed on the screen.
5.2 Measurement of Thickness / Height:

5.2.1 Place the tablet laterally between the jaws of Vernier Caliper. Make sure jaws shall just
touch object to be measured.
5.2.2 Tablet thickness shall be displayed on screen.
5.3 Measurement of Inner Diameter:
5.3.1 Inner diameter shall be measured with the help of upper jaw of Vernier Caliper.
5.3.2 By pressing zero key, 00 shall be displayed on the screen.
5.3.3 By pressing inch/mm display shows reading in inches / mm.
5.3.4 Place the tablet in between the upper jaws of Vernier Caliper by rotating the adjustment
screw. Make sure jaws shall just touch object to be measured.
5.3.5 Inner diameter shall be displayed on the screen.
5.4 Measurement of Depth:
5.4.2 Depth shall be measured on the screen by rotating the screw and keep Vernier caliper in
vertical position.
5.5 Cleaning Procedure
5.5.1 Switch ‘OFF’ the Vernier Caliper by pressing ‘OFF’ button.
5.5.2 Clean the equipment with the help of dry non shredding cloth.
5.5.3 After cleaning put the Vernier Caliper in box.
NA
7.0 Distribution
7.2 Controlled Copies – Production and Quality Assurance
8.0 History
– 00 New SOP
Operating Procedure of Air Handling Units and Ventilations Units

1.0 Objective
To lay down an Operating Procedure for Air Handling Units, Exhaust, Supply and Ventilation
Units.
2.0 Scope
This Standard Operating Procedure is applicable to the formulation plant of Pharmaceutical

Company.
3.0 Responsibility
3.1 The Concerned Technician shall follow the Operating Procedure as per this SOP
3.2 The Officer/Executive-Engineering shall be responsible for implementation of the procedure

as per this SOP.
4.0 Accountability
Head-Engineering/Designee shall ensure the compliance of the procedure as per this SOP.
BMS: Building Management System
DDC: Digital Display Control
MCC: Machine Control Center
RH: Relative Humidity
VFD: Variable Frequency Drive
RA: Return Air
AHU: Air Handling Unit
6.0 Procedure
6.1 In Manual Mode
6.1.1 Pre Startup Checkup
6.1.1.1 Ensure Power supply shall “ON” from MCC panel for all Air Handling Units, Exhaust
and Supply and Ventilation Units.
6.1.1.2 Ensure Chilled Water and Hot water circulation is going on. Working Pressure of Chilled
water and Hot water shall be more than 1 Kg/Cm2.
6.1.1.3 All VFD’s and Starters shall be in Manual/Local mode.
6.1.2 Starting Procedure
6.1.2.1 Start the core corridor AHU’s along with exhaust unit to maintain positive pressure in
core corridor.
6.1.2.2 Start the all other AHU’s along with ventilation units after 10 minutes of Core Corridors
AHU’s and Global Exhaust Units.
6.1.2.3 Record all the data after every three hours as per Annexure-I.
6.2 In Auto Mode
6.2.1 Pre Startup Checkup
6.2.1.1 Ensure Power supply shall “ON” from MCC panel for all Air Handling Units, Exhaust
and Supply and Ventilations Units.
6.2.1.2 Ensure Chilled Water and Hot water circulation is going on. Working Pressure of Chilled
water and Hot water shall be more than 1 Kg/Cm2.
6.2.1.3 All VFD’s and Starters shall be in remote/auto mode.
6.2.1.4 UPS power supply to BMS and all DDC panels shall be “ON”.
6.2.2 Starting Procedure
6.2.2.2 All AHUs, Global Exhaust, Global Supply and all ventilation Unit shall start through
BMS which is Programmed for as per following sequence:-
6.2.2.3 Core Corridor’s AHUs and Exhaust Unit shall start before 10 minutes of other AHUs as
scheduled.
6.2.2.4 After 10 minutes all other AHUs, Supply and Ventilation Units shall start as scheduled.
6.2.2.5 All AHUs are programmed for Design Temperature and RH settings. If there is any
change in room condition requirement then Engineering-Executive/ Officer can only change the
setting.
6.2.2.6 There are three level securities Password in BMS login.
6.2.2.7 One is primary level for operator. Operator shall be authorized for data checking only he
can also take printout of data like RA Temperature, RH.
6.2.2.8 Second level is for Engineering persons who can change the:
Room condition settings.

Change in Alarm setting.
To make new login for Operators
6.2.2.9 Third level is for Administrator. In this level only ABB Engineer is authorized to change
all setting, Change password of Second Level and reprogram the system.
6.2.2.10 Record all the data after every three hours as per Annexure-I.
7.0 Forms and Annexure
Logbook: Annexure – I
8.0 Distribution
8.1 Master Copy: Documentation Cell
8.2 Controlled Copies: Engineering, Quality Assurance, Quality control, Production, Warehouse,
Administration and House Keeping.
9.0 History
– 00 New SOP
Preventive Maintenance of Purified Water (Generation and Distribution)

System
1.0 Objective
To lay down a procedure for Preventive Maintenance of Purified Water System (Generation and
Distribution).
2.0 Scope
This Standard Operating Procedure is applicable for formulation plant (Company Name).
Make/Capacity and EQ ID No. are as follows:-
Sr. No. Make Capacity EQ ID No.
3.0 Responsibility
3.1 The Concerned Technician shall follow the procedure for Preventive Maintenance as per this
SOP.
3.2 The Officer/Executive-Engineering shall be responsible for implementation of this procedure

as per this SOP.
3.3 Head-Engineering/Designee shall ensure the compliance of this SOP.
4.0 Accountability
Head-Engineering
consistently.
UV : Ultra Violet
FRC : Filter Regulator and Connector
RO : Reverse Osmosis
LPH : Liter Per Hour
TC : Tri Coupling
6.0 Procedure
6.1 Monthly Schedule

6.1.1 Switch “OFF” the main power supply through MCC and hang the Preventive Maintenance
Display Board on the electrical control panel.
6.1.2 Check all pressure switches for proper functioning.
6.1.3 Check and note the reading of hour meters of all UV lamps and change the UV lamp
between 7200 hours to 7500 hours.
6.1.4 Clean all S. S. visible part of purified water system by coline and cloth properly.
6.1.5 Checked, all pressure gauges for proper functioning, if not working, replace with same
range calibrated gauge.
6.1.6 Clean all panels by vacuum cleaner and duster.
6.1.7 Check all TC joints for leakages, if leakage found change its silicon gasket.
6.1.8 Checked dosing pump, cleaned its suction & discharge pipe with air & water pressure.
6.1.9 Check all indicators change if fused.
6.1.10 Check all electrical connections, MCB, push button & switches for proper functioning.
Rectify if required
6.1.11 Check three way valves for smooth functioning, lubricate if required.
6.1.12 Check all diaphragm valves for proper functioning change, if faulty.
6.1.13 Clean the Prefilter and air vent filter if required. Change the Prefilter if pressure gauge
shows measure pressure drop upto 2 bar.
6.1.14 Check all pumps for any leakages and smooth operation, rectify if found any abnormality.
6.1.15 Check the all motors for the loose connection and smooth operation and apply grease on
the bearing and change the bearing if necessary.
6.1.16 Record all the observations in Preventive Maintenance Checklist (Annexure-I).
6.2 Yearly Schedule
6.2.1 Check all pneumatic valve for proper functioning change if found faulty.
6.2.2 Change the Prefilter and Vent filter with a new filter after every 2 years.
6.2.3 Change MCF filter after every two years or as and when required.
6.2.4 Record all the observations in Preventive Maintenance Checklist (Annexure-I).

7.1 Preventive Maintenance Log Sheet : Annexure-I
7.2 Spare Parts List : Annexure II
SOP of SOP.
9.0 Distribution
9.1 Master Copy : Documentation Cell (Q.A.)
9.2 Controlled Copies : Engineering, Quality Assurance, Production, Stores, Quality

Control, Administration and House keeping
10.0 History
00 New SOP
Annexure-I
PREVENTIVE MAINTENANCE CHECKLIST
Machine Name: Purified Water System Identification No.:
(Generation and Distribution)
Date of Maintenance / Cumulative Operating Hours:
Next Due Date / Due at Cumulative Operating Hours:
Status Remarks
Sr.No. Parameter Check for
OK Not OK
Monthly Schedule
Power Supply Switch OFF
P.M. Display Board Hang On Electrical Panel

UV lamp Running Hours
S.S. Parts Cleanness
Functioning and
Pressure Gauges
Calibration
Panel Cleanness
TC Joints Leakages
Dosing Pump Cleanness and leakages
For Looseness and Over

Electrical Connection
heat
Pre Filter & Vent Filter Cleanness, Damages
Nut & Bolts Tightness, Damages
Comments for any repairs etc. (If space is insufficient attach separate sheet for recording)
Done By Approved By Approved

By
(Sign & Date) Engineering Dept. Concerned

Dept.
(Sign & Date) (Sign &

Date)
Annexure-II
Spare Parts Used
Name of Machine: Purified water System (Generation and Distribution) Identification No.:
S.NO. Part No. Description Quantity

Done By Checked
By
(Sign & Date) (Sign &

Date)

SOP on Issuance, Preparation, Storage, Usage and Disposal of Disinfectant

Solution.
1.0 Objective
To lay down a procedure for issuance, preparation, storage, usage and disposal of disinfectant
solution.
2.0 Scope
This SOP is applicable for issuance, preparation, storage, usage and disposal of disinfectant
solution in __________(Company/Place name location).
3.0 Responsibility
GMP coordinator is responsible for the issuance of the disinfectant solution.
GMP coordinator shall responsible for receipt, storage, usage and disposal of disinfectant
solution.
Head of concerned departments shall be responsible for implementation of the SOP.
4.0 Accountability
Concerned Department Head & QA Head shall be accountable for the compliance of this SOP.
IPA : Iso Propyl Alcohol
% : Percentage
V/v : Volume/Volume
W/v : Weight/Volume
W/w : Weight/Weight
ml : Milli Liter
SS : Stainless Steel
Ltr. : Litre
DM : De-mineralized
BP/IP : British Pharmacopoeia/Indian Pharmacopoeia

6.0 Procedure
6.1 Usage of Disinfectant Solution:
6.1.1 Disinfectant solution shall be used for following:
Surface disinfection
Hand disinfection
Equipment sanitization
Spray disinfection
Dilute disinfectant solutions shall be used for cleaning in both manufacturing, packing and
warehouse area.
6.2 Issuance of Disinfectant solution
6.2.1 All disinfectant solution except IPA shall receive by GMP coordinator and shall store in
designated place.
6.2.2 IPA shall receive by warehouse.
6.2.3 Following disinfectant shall be used in premises for cleaning & sanitization:
Name of
S. No. Concentration Composition Application
disinfectant
Hands and Surface

1. IPA 70% Isopropyl alcohol
Disinfection.
Chloroxyfenol I.P.4.8%w/v
Dettol Antiseptic Terpineol B.P.9.0%v/v General Cleaning

2. 2.5%
Liquid AlcoholAbsolute13.1% and Disinfection
Contains Caramel I.P as Colour
Diolkyl/dimethyl ammonium chloride

General Cleaning
3. Pursue 0.8% and Alkyldimethylbenzyl ammonium
and Disinfection
chloride-3.8%
Benzalkonium Chloride I.P. 4% w/v General Cleaning

4. Dazzl 4.5%
and Carmosine and Disinfection
General Cleaning
5. Cetrimide 2% Cetrimide
and Disinfection
Chlorhexidine Gluconate – 5gm General Cleaning

6. Savlon 2.5 %
(0.3%w/v), Cetrimide – 15gm (3%w/v) and Disinfection
 6.2.4 GMP coordinator shall issue disinfectant solution (except IPA) to housekeeping
personnel on daily basis through material issue slip IPA shall be issued by warehouse to
GMP coordinator through material issue slip.
6.3 Distribution of disinfectant solution
6.3.1 Intact container of disinfectant solution shall distribute to respective area.
6.3.2 Distribution record disinfectant solution shall maintain in the “Receiving and
distribution of Disinfectant Solution” (Annexure-I).
6.3.3 Consumption record of disinfectant shall maintain area wise in the “Disinfectant
6.3.4 The disinfectant solution shall be stored in the respective places in manufacturing,
packaging and warehouse area.
6.4 Preparation of disinfectant solution shall be done as follows
6.4.1 After issuance disinfectant solution shall be prepared in respective area by housekeeping
personnel in presence of area Incharge.
6.4.2 Disinfectant solution shall prepared & rotate on daily basis.
6.4.3 70% IPA solution shall be used as hand disinfection as such as it is available.
6.4.4 Dilution of other disinfectant solution shall be prepared as follows:
6.4.4.1 A clean fiber bucket shall be used for preparation of disinfectant dilute solution.
6.4.4.2 Required quantity of DM water & disinfectant (as mentioned in point 6.2.3) shall
measure through graduated measuring cylinder and transfer to bucket.
6.4.4.3 To form a consistent solution, solution shall mix by using SS rod.
6.4.4.4 Dilution of disinfectant solution shall prepare as per requirement by using following
standard:
Volume to be
Volume of Volume of DM
S. No. Name of Disinfectant Concentration Prepared
Disinfectant (mL) Water (mL)
(mL)
1. Dazzl 4.5% v/v 450 9550
2. Pursue 0.8% v/v 10000 80 9920
3. Cetrimide 2% w/w 200 800

Volume of Volume of
S. Name of Volume to be
Concentration Disinfectant DM Water
No. Disinfectant Prepared (mL)
(mL) (mL)
Dettol Antiseptic
4. 2.5 % v/v 250 9750
Liquid 10000
5. Savlon 2.5 % v/v 250 9750
 6.4.4.5 Disinfectant preparation record shall maintain as per “Receiving and distribution
of Disinfectant Solution” (Annexure-I).
6.4.4.6 Distribution record of IPA shall maintain on same Annexure I.
6.5 Disposal of Dilute Disinfectant Solution
6.5.1 After completion of the sanitization activity, discard the left over disinfectant solution by
pouring the solution into nearest drain of respective area.
6.5.2 Record the consumption and destruction of disinfectant solution in the “Disinfectant
6.6 Precautions
6.6.1 Protective wear is must while preparing the disinfectant solution.
6.6.2 Avoid spillage of disinfectant solution on the floor while preparation.
6.6.3 Do not use expired solution for cleaning.
7.1 Receiving and Distribution of Disinfectant Solution – Annexure-I
7.2 Disinfectant Consumption and Destruction Record – Annexure-II
8.0 Distribution
8.2 Controlled copies- Quality Assurance, Production, Quality Control, Stores, Engineering, and
Human Resources.
9.0 History
Revision
Number
– –
Annexure-I
Receiving and Distribution of Disinfectant

Solution
Name of Disinfectant_________________________ Use before

Date_____________________
Date of Quantity Received by Distributed Name of Issued Received By Balance

Remarks
Receiving Received (Sign/Date) by Area Qty. (Sign/Date) Quantity

Format No.
Annexure-II
Disinfectant Consumption and Destruction Record
Area Name________________ Qty. of Disinfectant Standard

Pack_______________
Name of Disinfectant____Concentration of Disinfectant Solution______Use before

date_________
Qty. of Remaining
Qty. of DM Total Qty. Balance Prepared by Checked by
Date of Disinfectant Qty.
Water Prepared Quantity of
Preparation Solution used (Sign & Destroyed by (Sign &
(Ltr.) (Ltr.) Disinfectant Date)
(Ltr.) (Sign & Date) Date)
Format No:
SOP for Assigning of Identification Numbers to Equipments, Sub-Equipments
Objective
To lay down a procedure for Assigning of Identification Numbers to Equipments, Sub-
Equipments and In-process SS items in various departments.
 Scope
This SOP is applicable for Assigning of Identification Numbers to Equipments, Sub-Equipments

and In-process SS items in various departments
Responsibility
 Head of departments or his / her designee shall be responsible for assigning ID. Nos. to
equipments, sub-equipments and in-process SS items of their respective departments.
 Head-Quality Assurance shall ensure the implementation and compliance of this SOP.
 Accountability
o Department Head & QA Head shall be accountable for implementation of this
SOP.

 No. : Identification Number
 Sub-Equipment : The sub equipments are the equipments installed on the main
equipment meant for recording various process parameters during run of that equipment.
 SS : Stainless Steel
 In-process SS Items : Any SS item which is supposed to be in direct contact with
the product or its ingredients during dispensing, sampling or manufacturing operations.
 Procedure
Note: The numbering of Sieves and Screens shall be done as per SOP titled “Control
of Sieves and Screens of different equipment” (——–), numbering of Change Parts of various
equipments shall be done as per SOP titled “Control of Change Parts” (———) and numbering
of Dies and Punches shall be done as per “Control of Dies and Punches” (———).
 Equipment Numbering: Equipments installed in various departments shall be assigned

unique ID. No. as per the steps discussed below.
o The first and second character shall be ‘EQ’ denoting equipment.
o The third character shall be ‘/’ (slash).
o The fourth and fifth character shall denote the department in which equipment is
installed. The codes for each department shall be as follows:
PR : Production
EN : Engineering
AH : Administration and Housekeeping
ST : Stores (RM and PM)
WH : Finished Goods Warehouse
 The sixth character shall be ‘/’ (slash).

 The seventh, eighth and ninth characters shall be the numerical digits for the serial
number of equipment. The first number of the equipment shall be 001, 002, 003 and so
on.
E.g. the complete ID. No. of equipment installed in Production department shall be EQ/PR/001
and Quality Control shall be EQ/QC/001 respectively.
 All equipments with same make, design, function or use shall be given separate ID. No.
 List of equipments installed at various departments shall be prepared by respective
departments as per the format attached as Annexure-1 and shall be distributed to QA on
need basis (whenever there is a change or installation of new equipment) or monthly;
whichever is earlier.
 Sub-Equipment Numbering: Sub-Equipments like vacuum gauges, pressure gauges,

pumps, detectors, data loggers etc. installed on equipments in various departments shall
be numbered as follows:
o The sub equipment numbering shall consist of eleven (11) characters.
o The first six characters of sub-equipment numbering shall be same as the last six
characters of the Equipment ID. No. assigned to the main equipment on which the
sub-equipment is to be installed (Refer steps described under point 5.1).
o The seventh character shall be a dash ‘-’.
o The eighth and ninth character shall be two characters representing the type of
sub-equipment like, VG for vacuum gauges, PG for pressure gauges, PU for
pumps, DT for detectors, DL for data loggers etc.
o The tenth and eleventh characters shall be numeric digits starting from 01 for the
first item of the same type e.g. vacuum gauges installed on leak test equipment
installed in production department heaving Equipment ID. No. EQ/PR/004 shall
be numbered as PR/004-VG01.
Note: If different types (w.r.t. their application) of sub-equipments are having identical two
principal characters derived from their nomenclature, then their numbering can be made distinct
by taking one more character, hence making numbering of sub-equipment of twelve characters,
e.g. DPT can be assigned to represent the differential pressure transmitter and DPS for
differential pressure sensor.
 List of sub-equipments installed on equipments in various departments shall be prepared
by respective departments as per the format attached as Annexure-2 and shall be
distributed to QA on need basis (whenever there is a change or installation of new
equipment) or monthly; whichever is earlier.
 Numbering for In-process SS Items: All in-process SS items with capacity more than
30 kg approximately like Storage Bins, mugs, spatulas, spoons, scrappers, buckets,
sampling aids etc. shall be numbered as follows:
o The in-process SS item numbering shall consist of five (05) characters.
o All the contact items shall be numbered in a three digit (started as 001) serial no.
with the prefix of ‘SB’ for storage bins, drums, vessels and buckets; ‘BB’ for
blender bins; ‘MG’ for mugs and measuring cylinders; ‘SP’ for
spatula/spoons/scrappers and ‘SA’ for sampling aids.
e.g. complete identification number of spoon to be used in Stores (RM and PM) shall be
numbered as SP001 and in-process SS storage bins to be used in Xeed block shall be numbered
as SB300.
 The three numeric characters (started as 001) shall be allotted as per following system:
001 to 099 Stores (RM and PM)
100 to 299 Production Block
300 to 399 Xeed Block
400 to 499 Herbal Block
500 to 599 Soft Gelatin Block
600 to 699 Quality Control
 The allotment of each identification number to each in-process SS items shall be

maintained in the register as per the Annexure-3.
 For SS items having capacity less than 30 kg approximately, set number shall be assigned
as per SOP number BF-PD-034.
 The identification number on each equipment, sub-equipment and in-process SS items

shall be conspicuously written.

o Format for List of Equipments : Annexure-I
o Format for List of Sub-Equipments : Annexure-II
o Format for List of In-process SS Items : Annexure-III
 Distribution
o Master Copy : Documentation Cell (Quality Assurance)
o Controlled Copies : Production, Quality Control, Engineering, Administration and
Housekeeping, Stores, Finished Goods Warehouse, Quality Assurance
 Reference:
If any
 History

Reason for Revision
SOP for Access Control System, Numbering and Usage
Objective
To lay down a procedure for assigning of identification numbers to access control system and
usage of the system.
Scope
This Standard Operating Procedure is applicable to various departments of identification

numbers to access control system.
 Responsibility
Head-User department shall be responsible for sending the request to QA department for
authorization of the different personnel’s for entering in their respective areas.
Head-QA/Designee shall be responsible for approving the request as per this SOP.
Head-HRD/Designee to record all authorization given to concerned.
Head-Engineering/Designee shall be responsible for assigning numbers to assess control

systems.
Head-IT/Designee shall be responsible for the technical support of the access control to HRD.
Head-Concerned department/designee shall be responsible for receiving the visitors (arriving for
particular department job) and there movement within thepremise.
Head-QA/designee shall be responsible for receiving the auditors and there visitinside the plant
and providing the access cards (if required).
Head-Quality Assurance shall ensure the implementation and compliance of this SOP.
All users to follow the entry/exit procedure as per this SOP.
 Accountability
SOP.
ID.No. : Identification Number
HRD : Human Resource Department
Access Control System : An access control system determines who is allowed to
enter or exit, where they are allowed to exit or enter, and
when they are allowed to enter or exit.
HOD : Head of Department
 Procedure
o Request for Permit
Head-User department/Designee shall send the request on annexure-1 to QA for giving the
permit to enter in the respective area.
Head-QA/Designee shall review the request and forward the copy of the same to
Head-HRD/Designee.
Head-HRD/Designee shall forward the request (after approving) to Head-IT/Designee for
technical support.
Head-IT/Designee shall provide the access to concerned personnel’s in their respective working
area as per the approved request.
Records of the same shall be kept by HR department.
Access shall be provided to all users on their punch cards.
In case of personnel visiting the plant from other location (within Plant ) for some official work,
Head-HRD/designee shall provide the access cards to those personnel with restricted area entry
depending upon the classification of work and the area in which there work is allotted.
In case of personnel those are not on company payroll/ contractual basis and are working on the
production shop floor or any other location where access is required, access card shall be
provided to those personnel by security personnel at the time of entry in the premise and the
same shall be deposited back at the same place while exit from company premise.
Security personnel shall give the access card to the personnel, while taking his/her signatures in
the entry register along with the access card number (with restricted entry).
Note: – Department Heads of all the concerned departments shall have master card having access
to all areas.
Entry/Exit Procedure
While entering or exit form the area, personnel’s have to show their access/punch cards in front
of the sensor, until acceptance for the same has been accounted.
If the person has the access, he can open the doors and if the person does not have the access he
cannot open the doors.
Numbering System for Access Control System
Each access control unit is divided into two categories
Controller and Locks, each controller unit comprise of four locks.
Number procedure of Controllers, Controller numbers shall start with C01, C02, C03,
C04 and so on.
Lock numbers shall be assigned with unique characters.
Lock numbers shall consist of alpha-numeric characters as “XYY”.

 “X” denotes respective area.
 “YY” representing the numbering e.g. 01, 02, 03 and so on.
 All department codes shall be given in “Annexure-2”.
Precautions during usage of access control cards
In case of any exigency, break the glass of emergency exit release and press—*—.
Do not forcefully try to open the door if you are not authorized to enter in that particular area.
Do not touch the sensor of the access control system with hand or with any other metallic items.
In case of lost/discrepancies in the card immediately inform Department-Head about the same in
order to discontinue the authorization in the respective area.
Head-Concerned department/designee shall intimate the same to Head-HRD/Designee for further

processing.
All records related to permit of the personnel’s shall be retained by HRD.
New joinees shall be given the master card (having restricted entry to particular areas) on
permission of respective HOD on annexure-1, until they got their personal access card.
In case of any type of exigency, Head-IT/designee shall discontinue the access control system so
that each individual shall depart from that particular area, also in case if some technical fault
arose in the system individual should break the doors with the usage of hammer (provided at
critical junctures).
Area wise distribution of controllers and lock is mentioned in annexure-4.
Note: This is a makeshift arrangement and shall be pertinent for only three month, after three
months a complete investigational report shall be prepared by Head-HRD/designee in order to
verify the applicability of the system and after the review of verification report SOP shall be
revised.
Verification report is based upon the individual movement in a particular area and its tracking
within the software.
Forms and Records (Annexures)
 Access control request – Annexure-I

 List of departmental codes – Annexure-II
 Location of Access Control system – Annexure-III
 Numbering and allocation of Controller and Locks – Annexure IV

Distribution
Master Copy : Documentation Cell (Quality Assurance)
Controlled Copies : Production, Quality Control, Engineering, Administration

and Housekeeping, Stores, Human Resource department, Quality Assurance .Reference:
If any
History

Reason for Revision
Sop for Monitoring of Temperature, Relative Humidity and Differential

Pressure
 Objective
To lay down a procedure for monitoring Temperature, Relative Humidity and Differential
Pressure of microbiology lab.
 Scope
This SOP is applicable for monitoring and recording the temperature (0C), Relative humidity (%)
and differential pressure (mm of water) using digital hygrometers and Magnehelic gauge for
Differential Pressure in microbiology lab.
 Responsibility
o Microbiologist responsible for monitoring and verification of Temperature,
Relative Humidity and Differential Pressure.
o Head-Concerned department is responsible to ensure the prevailing Temperature,
Relative Humidity and Differential Pressure is within limits as per SOP.
 Accountability
SOP.
°C : Degree Centigrade
RH : Relative Humidity

mm WC : Millimeter of water column
Min : Minimum
Max : Maximum
HVAC : Heating Ventilation Air Conditioning
 Procedure
o Check the calibration status of the instrument.
o Check the temperature and relative humidity displayed in the digital hygrometer
monitor.
o Record the Temperature and Relative Humidity at starting of the shift + 30 min
and after every 4 hours ± 30 minutes for production, warehouse till completion of
the activity or end of shift whichever is later as per Annexure – I.
o Location:
Media Preparation Room
MLT and LAL Testing Room
Sterility Lab
 Acceptance Criteria:
Temperature: NMT (Not More Than) 250C
Relative Humidity: NMT 60%
 Procedure for monitoring of Temperature and Relative Humidity by Digital

hygrometer (Model: HTC-1)
o Record the previous day minimum and maximum Temperature and Relative
Humidity.
o Recording of previous day minimum and maximum Temperature & Relative
Humidity shall be performed at the time of observing daily initial reading.
o Record the minimum and maximum Temperature and Relative Humidity by
pressing “Memory” key. Press one time memory key to record max. Temperature
& max. Relative Humidity of previous day and again press memory key to record
min. Temperature & min. Relative Humidity.
o Delete the minimum and maximum reading from the memory of hygrometer that
is required to leave memory space to record the next day min. and max. reading.
o For resetting the minimum & maximum value, press “RESET” button provided
back side of the digital hygrometer with the help of pin.
 Procedure for monitoring of Differential Pressure in Different Areas
o Enter in the respective area and ensure that all doors of microbiology are tightly
closed.
o Ensure that the HVAC is in running condition.
o Open the door of respective area and ensure zero (0) set, while door is opened.
o Take the magnehelic gauge reading in the reference of positive and negative
pressure of rooms.
o Record the value.
o Location:
Media Preparation
Media Preparation Air lock
Change Room
MLT and LAL Testing Room
Corridor
Buffer Room
Sterility Room
Frequency: Twice a day (Morning and afternoon)
Acceptance criteria :

o Temperature and Relative Humidity Record – Annexure-II
o Record for Differential pressure – Annexure-III
 Distribution
o Controlled copies – Microbiology Lab
 Reference:
If any
 History
Reason for Revision
SOP on SOP (Preparation, Approval and Control of Standard Operation

Procedure) )
1. Objective
To lay down a procedure for the preparation, approval and control of Standard Operating
Procedures
2. Scope
Standard Operating Procedures to be followed at……….. (Plant Name & Location).
3.0 Responsibility
 Staff, Initiator Department shall be responsible for:

o Development or generation of draft(s) of new SOP as per the procedure given in
this SOP.
o Updation of the existing SOP whenever required.
 Head / Section Incharge or his / her designee, Initiator Department shall be responsible
for:
o Review and verification of SOP
o Training of the user staff.
o Approval of SOP
 QA Inspector/IPQA , above or his / her designee shall be responsible for:
o Checking and developing, if applicable, word processing styles and formats for
SOPs; printing out the finalized SOPs.
o Issuance of a unique number for new SOP.
 Head / Incharge, Quality Assurance or his/her designee shall be responsible for:
o Review of SOP for its correctness and adequacy with respect to regulations/
guidelines or company standards related to written procedures, if applicable.
o Final approval and subsequently compliance of the SOP.
 Accountability
SOP.
instructions
are cited to serve as support for methods or manners of

fulfilling a function or functions reliably and consistently.
 Procedure
o An SOP shall be written in short, clear sentences and preferably in a passive
voice, SOP should be easy to understand / follow and shall depict the sequence of
activities logically.
o Competent technical staff shall prepare SOP on format No. SOP/XQA-001/F01 as
given in Annexure-I
o A person directly supervising the operation shall initiate the SOP.
o A SOP shall be written after thorough understanding of the operating procedures.
The author of the SOP shall have adequate knowledge, training and experience in
the related areas of operation. Wherever necessary, some illustrations, drawings,
flow charts or exhibits may be incorporated in the SOP, to provide better clarity
and understanding.
o Wherever abbreviations are used, these shall be elaborated in point no. 5.0
“Abbreviations & Definitions”.
 Language of SOP
o The language used in SOP shall be clear, instructive, sequential, unambiguous
 and English language shall be used.

 Where required, for operational purpose, if any SOP is required to be translated in
vernacular language, the same shall be done by the initiator department by preparing draft
of SOP. Once the concerned SOP is finalized by QA using same form (form No.
SOP/QA-001/F01) and shall be finally approved by QA along with its main SOP in
English language. QA shall maintain the distribution and retrieval record of this SOP
separately as per SOP No. (————) “Titled-Document and Data Control”.
 SOP no. of this local translated SOP shall remain same as English language SOP.
 If there is a revision and / or change in the original SOP, the SOP in vernacular language
shall also be revised for the desired changes.
Initiation of new SOP

o For new SOP, Concerned Department personnel shall prepare the draft of SOP on
format of SOP (as per format no. X/QA-001/F01) and “DRAFT” shall be written
in diagonal using application watermark as shown below:
 After completion of draft the user shall send it to the Department Head for review.
 Department Head shall review the draft SOP, put the remarks or suggestion if any and
forward it to QA Deptt.
 QA personnel shall review the draft copy of SOP, write the comment if any and send it to
QA Head for final approval.
 QA Head or his/her designee shall review the draft copy of SOP and if suggested then
necessary corrections shall be done by concerned department personnel.
 After getting satisfactory correction and changes, QA Head or his/her designee shall
approve the draft of SOP by making his initial.
 After approval of draft, corrected soft copy of SOP shall be submitted by the concerned
department to QA, concerned dept. shall delete the soft copy of respective SOP from their
computer after handover it to QA.
 QA personnel shall take the printouts of SOP in black ink on A4 size white paper (on one
side of the paper only).
 In case of the rejection of the SOP draft by QA head or his/her designee the same shall be
maintain in documentation cell by QA personnel.
 SOP Numbering system

o Each SOP shall have a unique numbering system. Once number is allocated to
any SOP the same number shall not repeated any SOP. Description for SOP
numbering system is as follows:
o Numbering system
 Each SOP number consist eight alphanumeric character. For example first SOP prepared
in QA department shall be numbered as X/QA-001.
 The first alpha character indicates the location code where “X” indicates plant location.
 The Second character shall be ‘/, (Slash).
 Third alpha character indicates the department code and 4th alpha character indicates the
subsection/area code for the departments as per List of Department Name with code –
Annexure-II
 For the department’s 3rd and 4th alpha characters indicates department code other than
annexure-II. Department code mentioned in Annexure-III.
 The fifth character shall be a ‘-’ (dash).
 The sixth, seventh & eighth characters are numbers, which shall denote serial number of
the SOP. The first SOP of any department shall be 001. The subsequent serial numbers
shall be 002, 003, and so on.
 g. X/QA-001.
 Revision number of the next version of SOP shall be defined as per the issue number of
the previous version of SOP.
 Formatting of SOP
o All SOPs shall have a standard common format for page layout as per annexure I.
o An SOP shall be neatly typed using Microsoft Word application software
o Page set up of word file for SOP preparation shall be as follows:
 Orientation of page shall be portrait. Landscape orientation shall also be
used in annexures
 Paper size shall be A-4 with width of 8.27 inch and height of 11.69 inch.
 Margins setting on word file shall be as follows:
o Top margin shall be 0.8 inch (0.8”)
o Bottom margin shall be 0.6 inch (0.6”)
o Left margins shall be 0.6 inch (0.6”)
o Right margin shall be 0.6 inch (0.6”) as described below:
 Page Layout from edge shall be header 1.0” and Footer 0.4”.
 Page border’s line width shall be 1 point (1pt) as appears in this SOP.
 Line spacing between the lines shall be as follows:
o Before: 0 pt
o After: 0 pt
o Line Spacing: Single
 All the points in the SOP shall be numbered sequentially. Similarly the sub-paragraphs of
each point shall also be numbered sequentially, with an incremental number derived from
the heading number. A outline system of numbering shall be followed as follows: First
level shall be 1.0, 2.0, and 3.0 …….so on, Second level shall be 1.1, 1.2, 1.3……..so on,
this shall continue up to fifth level and fifth level shall be 1.1.1.1.1, and after this level
sub-numbering can be marked as ‘a’, ‘b’ and so on or ‘i’, ‘ii’ and so on. This sequence
shall be start from the heading of responsibility.
 In case where numbering of sub-paragraphs are not necessary and listing is essential,
bullets or other suitable identification marks may be used to illustrate the same.
 Contents of SOP
o All contents of SOP shall be written by using “Times New Roman” font.
o SOP content shall be divided into three parts:
 Contents of Header
 Contents of SOP Body
 Contents of Footer
 Contents of Header: contents of header is as follows:

o Header shall start from the top where name of SOP initiator department shall
write at the top right side with regular & bold letter in font size 12. Below this a
header table shall place.
o First column of this table shall have company Logo and in second column name
of the company in font 14 with caps and bold letter shall be mentioned.
o All the contents of header table shall remain same for all SOPs except the ‘Title’
and content for ‘SOP No.,’ ‘Revision No.’ ‘Supersedes’ & ‘Page no.’.
o Description of heeder content is as follows:
 Title: Subject of the SOP as per SOP no. shall be write
 SOP no.: SOP no. shall be written as described in point no. 6.8
 Revision No.: Revision no. shall be denoted in two numeric characters.
New SOP shall carry Revision No. ‘00’ and the subsequent revisions shall
be denoted by 01, 02, 03 and so on. (To be typed in regular font with font
size 11).
 Supersedes: Superseded number of the SOP shall be given in this column.
For example, SOP/QA-001 (the first SOP of QA) when prepared for the
first time (first version or edition), ‘Supersedes’ column shall be filled
with the word ‘None’ and when the same is revised for the first time,
‘Supersedes’ shall be given as ‘SOP/QA-001, Rev.00’ and the ‘Revision
No.’ for this SOP shall be filled as ‘01’.
 ‘Page No.’: Page no. shall be numbered in page X of YY & (for page 1 to
9) XX of YY format, e.g. first page of SOP of total 05 pages shall be 01 of
05. (To be typed in regular font with font size 11)
o The sequence of signature in SOP header column shall be described as follows:
 SOP initiator shall write their name, designation and sign with date by
hand in columns ‘Prepared by’.
 QA personnel shall review the SOP and write their name, designation and
sign with date by hand, in ‘Checked by’
 First Department Head/designee and Head or Incharge, QA or his / her
designee shall also write their name, designation, sign with date in the
column ‘Approved by’ hence approving the proposed SOP for
implementation.
o Effective Date: ‘Effective Date’ is the date when the content of SOP becomes
operational for the user department(s). It shall be given by QA department after
completion of training on the approved SOP, in DD/MM/YY format, by hand
o Next Review Date: The ‘Next Review Date’ shall be after two years from the
Effective Date of the SOP given by QA department in DD/MM/YY format, by
hand. Every SOP shall be reviewed within one months of the Next Review Date,
or earlier, if any amendment is required. E.g. if effective date of document is
15/01/12 then next review date for it shall be 14/01/14.
 Contents of SOP Body

o The content of Standard Operating Procedure (prepared in the format Annexure-
1) shall contain the following headings:
 Objective: as first point; an overview of the intention of preparation of
Standard Operating Procedure shall be briefly mentioned under this
heading. The ‘Objective’ shall always start with the word ‘To’.
 Scope: as second point; describes the site(s) / location(s) / plant(s) and/ or
departments to which the Standard Operating Procedure is applicable.
 Responsibility: as third point; specifies designation of the personnel and
name of department that shall be responsible for implementation and
compliance of the Standard Operating Procedure.
 Accountability: as fourth point; Deptt. Head and Head QA shall be
accountable for implementation and compliance of the Standard Operating
Procedure.
 Abbreviations and Definitions: as fifth point; describes the meaning or
explanation of term(s) which is (are) not common or having any specific
meaning and expansion of abbreviation(s) used in the Standard Operating
Procedure.
 Procedure: as sixth point; describes the detailed procedure to be followed
in simple and clear sentences. It may include the details of all operations,
operational conditions and precautions to be taken, if any, etc.
 Forms and Records: as seventh point; it shall enlist all specimen formats,
specimen labels, flow charts or any other attachment with the SOP.
 Reference : List other sop which directly affected or are relevant to the
procedure.
 Distribution: as eighth point; describes the distribution of the SOP to
various concerned departments.
 History:as ninth point; history shall contain a chronological record of
significant changes / modifications in an SOP in brief, mentioned in three
columns, namely: ‘Date’, ‘Revision Number’ and ‘Reason for Revision’
Note: Under ‘Date’ put date of preparation of the SOP. Under ‘Revision Number’ current
revision number of the SOP shall be mentioned. Under ‘Reason for Revision’ give reasons why
the SOP at previous revision number is modified. In case of new SOP write ‘New SOP’ under
‘Reason for Revision’ and in case of routine revision when the revision is not being addressed
through change control procedure, write ‘Routine Revision’ under this column. (For more clarity
refer ‘History’ at point no. 8.0 of this SOP)
 Narrative text of each heading shall be aligned below the heading, not across the length
of the heading.
Note: Method or procedure adopted for typing the text for this SOP shall be used as reference for
the typing of SOPs.
 Recordings, if required, as a result of implementation of an SOP shall be discussed in the

relevant SOP by defining a format for the recording purpose which is termed as ‘Format’
of the SOP and shall be annexed to the SOP.
 Contents of Footer
o Only Format no. shall write in footer. Format no. shall be written at left side
corner of the page and outside of page border
o Format number shall be typed in footer as ‘Format No.: X/QA-001/F01-00’, in
regular fonts in font size 10.
 Training
o Once the concerned SOP is approved by Head or Incharge QA, Initiator
department shall conduct training of the SOP and evaluation of training
thereupon, as per respective SOP on ‘Training of Personnel’.
Note: If a department prepares an SOP that involves other departments(s) in its execution, then
the persons from this (these) department(s) shall also be trained.
 Department Head shall ensure that training is imparted to all concerned.

 After completion of training on SOP, the initiator department shall forward the SOP
along with training record to QA.
 QA personnel shall attached the training record with SOP and retain the records as per
SOP on document control ‘SOP no. (…………)’. Preparation of Master Copy, Controlled
Copy, Issuance and Distribution of SOP.
o Master Copies and Controlled Copies (for distribution) of the SOPs shall be
prepared by QA as described in SOP on ‘Document and Data Control’ (SOP
No…….).
o Issuance and distribution shall be done as per SOP ‘Document and Data Control’
(SOP No……).
 Revision of SOP
o Biennial review of an SOP shall be undertaken as per SOP ‘Document and Data
Control’ (SOP No……) however change in any SOP shall be undertaken through
SOP titled ‘Change Control’ (SOP No…..).
 Storage, archive, Obsoletion of Superseded SOP
o Storage, archive and Obsoletion of SOPs shall be done by QA as per SOP
‘Document and Data Control’ (SOP no.——).
 Uncontrolled Copies of SOP

o These are copies of SOPs made by photocopying the “MASTER COPY”, for
information purposes only. They are provided, for example, to regulatory or
certification authorities for their reference.
o Such copies shall be made by the QA personnel (as per SOP ‘Document and Data
Control’ SOP no.———-) with the knowledge and consent of the QA Head.
 Master List of SOPs

o QA shall maintain a master list of SOPs as per annexure III. It shall contain the
list of SOP’s of all the departments.
o Master list of SOPs shall approved by Head QA /designee.
o The list shall be revised as and when required.
o A hard copy shall be printed and signed by Head QA /designee and kept in QA
records as master copy.
 All the pages of SOP excluding annexures shall be signed and dated only in blue ink,
using ballpoint pen.
 All headings of SOP shall be in regular & bold letter and single space equivalent to font
size 12 shall remain between headings to next line.
 All designations and name of departments used in SOP shall start from capital letter.
 If any coloured photograph is required for SOP then it can be attached as a part of
annexure.
 A “flow chart”, detailing about the steps involved, may be attached in the SOP.
 Master copy and control copies of SOP shall not be stapled and punched.
 Content of Form and Records (Annexures)

o A suitable “Record format” shall be prepared for recording the control parameters
and included as a part of the SOP itself.
o A unique format number shall be assigned to theses format as described below:
 The format of the SOP shall be numbered with fifteen characters its
description is as follows:
 The first eight characters of the format number shall be derived
from the concerned SOP and the remaining seven characters shall
be as follows
 The ninth character shall be a ‘/’ (slash).
 The tenth character shall always be ‘F’ which denotes ‘Format’.
 The eleventh & twelfth character shall denote the Format’s Serial
Number ranging format 01 to 99.
 The thirteen character shall be a ‘_’ (dash).
 The fortieth and fifteenth characters shall denote the Revision
Number of the format. The first version of any format shall carry
Revision Number ‘00’. The subsequent revisions shall have
Revision Number 01, 02, so on. Example: Format number X/QA-
001/F09-00 is the first version of the ninth format of first SOP of
Quality Assurance.
 All recording formats of SOP shall be attached with SOP as annexures.
 A list of annexure(s), described in the SOP, shall be mentioned (along
with annexure number in section 7.0 written as forms and records.
 The annexure shall be written at the top of the page as “Annexure -I”. The
numbering of the annexure should be given in roman numerals as I, II and
so on.
 Page no. shall be written at the bottom of page (bold number 3) but in
format of SOP it shall be as define in Annexure-I.
 If there is a revision in the format, which does not affect the content of the
SOP, related department shall revise only annexures, not the whole SOP.
 For revising annexures, initiator shall fill change control format, and take
the approval of Department Head and QA Head.
 After approval of QA Head, Concerned Department Personnel shall revise
the annexures.
 Revised annexure shall prepared as master copy and then controlled copy
as per SOP on Document control (SOP no. :———-) and this new master
copy & controlled copy of annexure shall replace with previous copies.
 A separate distribution record shall be maintained for this type of
annexures.
 Procedure for recall of superseded annexures and obsolescence of
annexure shall be same as SOP (as per SOP on Document control, SOP
no. :———-).
 Other than formats any picture, list, flow chart etc. related to SOP may be
attached with SOP in format of annexure.
 Annexure shall also have the signature columns and stamping shall be
made in all annexures.
o Format for Standard Operating Procedure – Annexure-I
o List of Department Name with code – Annexure-II
o Department wise code for SOP numbering system for other departments –
Annexure – III
o Master List of SOPs – Annexure-III
 Reference (If any)
Not Applicable
 Distribution
o Controlled copies- Quality Assurance, Production, Quality Control, Warehouses,
Engineering & Human Resource Development
 History

Reason for Revision

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List of Standard Operating Procedure (SOPs) in Production – Oral

List of Standard Operating Procedure (SOPs) in Production – Oral

1. Entry and Exit procedure

To lay down a procedure for cleaning of the Primary Production Area.

2.1.1 Processing Rooms

2.1.2 Production Corridor Area

2.1.2 Production Corridor Are

2.1.3 Equipment wash area

2.1.4 Semi finished Product storage area and other areas.

4.1 Production Head.

5.0 Abbreviations and Definitions

SOP : Standard Operating Procedure

SS : Stainless Steal

6.1 Cleaning aids:

6.1.1 Dry Vacuum Cleaner : It is used for dry cleaning.

6.1.4 Duster Cloth : For cleaning

6.1.5 Domex / Lysol. : Disinfectant

6.1.7 Pipe brush : For floor cleaning

6.1.8 Floor cleaning trolley : For moping of pipe brush

6.2 Processing Room

6.2.2.1 Type-A: Applicable for Product to Product change over.

6.3 Type- A Cleaning

6.3.8 Clean the SOP stand using clean dry duster.

6.4 Type-B Cleaning:

6.5 Type -C Cleaning:

6.5.4 Clean the SOP stand using clean dry duster.

6.6 Production Corridor Area

6.6.2 Clean and mop the entire floor twice a day.

6.6.7 Clean the switchboards using dry duster.

6.7 Equipment wash area

6.7.2 Clean and mop the entire floor twice a day.

6.7.3 Tube light fixture cleaned once a week.

6.8 Semi finish Product storage area and other areas:

6.8.4 Clean and mop the entire floor twice a day.

7.0 Forms and Records (Annexures)

 Processing room cleaning record – Annexure-I

 Master copy – Quality Assurance

Date Revision Number Reason for Revision

Processing Room Cleaning Record

Disinfectant solution used: _____________________ Type of cleaning: A

Date Date Date Date Date Date

Note: Write A/ B/ C wherever applicable and write N.A. if not applicable.

Type-A: Applicable for Product to Product change over

Area:______________________ Disinfectant solution used:

Date Date Date Date Date Date

Head – Quality Control

5.0 Abbreviations and Definitions

SOP : Standard Operating Procedure; a document where step by step

QC : Quality Control

SG : Sub General

GMP : Good Manufacturing Practices

GLP : Good Laboratory Practices

6.1 Entry Procedure into Sampling Booth Area:

6.1.1. Enter into the personnel air lock area.

6.1.2. Take clean secondary gown.

6.1.4. Wear booties.

6.1.6. Enter into the Sampling booth area.

6.1.7. Hand gloves shall be used during sampling operation.

6.2 Exit Procedure from Sampling Booth Area: