Batch Manufacturing Record (Capsule) : Title

Document No. WB/PD/SOP/002-B Version No. 000.
Issue Date 25/03/2019 Effective Date 01/04/2019

Department Quality Assurance Supersede New
Title:
Page 1 of 25
Batch Manufacturing Record (Capsule)
1. Detail of Product:
Title of Product
Batch Number C.000
Initiation Date /2019 Mfg. Date Exp. Date
Please Pick One type
 Hard Shell Capsule

 Hard Shell
Capsule
CAPSULE  Soft Shell
Capsule Type (By Action) Selected Type
Type
 Modified-release
1. General General
capsules
2. Antibiotic
3. Psychotropic
4. Other
Color Shape
Quantity Batch Size No. of Capsules (App.)
Packaging
Storage Conditions
2. Product Batch Manufacturing Record Issuance:

I have reviewed the batch record to ensure that the copy is complete, all the data
is reviewed and accordingly.
Issued By: (QA
Department)
_____________________ ________________________
QA Officer (Sign & Date) QA Manager (Sign & Date)
I have reviewed the batch record to ensure that the copy is complete, I am
responsible for the Batch Record following issuance.
Issued To.
______________________ _________________________
Prod. Officer (Sign & Date) Prod. Manager (Sign & Date)
Title:
Page 2 of 25
3. Table of Contents:
S.No Topics Page Number
1 Detail of Product: 1
2 Product Batch Manufacturing Record Issuance: 1
3 Table of Contents 2
4 Referred Document(s): 3
5 Required Equipments: 3
6 Instructions for Production Department 3
7 Dispensing: 4
8 Mixing and Granulation: 7
9 Request for Analysis 9
10 Certificate of Analysis 10
11 Capsule Filling Process 11
12 In-Process Control Form During Capsule Filling 12
13 Batch Reconciliation (Filled Capsules) 13
14 Request for Analysis for Filled Capsules 14
15 Certificate of Analysis for Filled Capsules) 15
16 Batch Packaging Record 16
17 Material for Destruction/Return: 20
18 Yield Statement 21
20 Request for Analysis for Finished Product 22
21 Certificate of Analysis (Finished Product): 23
22 Finished Product Transfer Slip: 24
4. Referred Document(s):
S.No Document No. SOP Title
1.
2.
3.
4.
5.
6.
7.
8.
9.
Title:
Page 3 of 25
10.
11.
5. Required Equipments:
EQUIPMENT DETAILS
TYPE :
MODEL:
CAPACITY:
SIFTING :
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
BLENDER:
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
MIXER :
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
CAPACITY:
DRYING
MANUACTURER:
TAG.NO.:
SOP NO.
TYPE :
MODEL:
Capsule Filling CAPACITY:
Machine MANUACTURER:
TAG. NO.:
SOP NO.
TYPE :
Capsule Polisher
MODEL:
Title:
Page 4 of 25
CAPACITY:
MANUACTURER:
TAG. NO.:
SOP NO.
6. Instructions for Production Department:

6.1 All documents must be completely and clearly filled in, signed & dated by the concerned personnel.
6.2 Any correction(s) overwriting or changes must be initialed and dated. Use of Blanco / whiteners is
prohibited. In case of Documentation, must follow the SOP “Good Documentation Practices
(QA/SOP/005)”.
7. Dispensing:
7.1 Line Clearance Checks:
Steps Objectives Comments
Environmental Conditions Comply. Obs. Temp.:
7.1.1
Temperature: 20 ºC to 26 ºC & Humidity: 35 to 50% Obs. Humidity.:
Check for the cleanliness of area and record the same in the
7.1.2
checklist
Inspect the dispensing area and thoroughly check for any visible
7.1.3
contamination of previous product as per the checklist.
Recommend rewash, if visible contamination from the previous
7.1.4
product is noticed
7.1.5 All materials from previous operations have been removed
Equipment and accessories from previous operations have been
7.1.6
removed.
7.1.7 Paperwork from previous operations has been removed
Title:
Page 5 of 25
The reverse laminar flow booths and surrounding are clean and
7.1.8
status is displayed.
All the equipment and accessories required for dispensing are clean
7.1.9
and record is maintained.
Check that the differential pressure of the area is negative with
7.1.10
respect to the adjacent corridor.
7.1.11 The RLAF is working properly
7.1.12 The balances are calibrated.
The raw material for the name, batch number, QC Number, Expiry
7.1.13
Date and Retest Dates are OK and Observed.
.
I have confirmed the above stated requirements are fulfilled and the area is clear for
dispensing.
Confirmed By.
______________________ _________________________
QA. Officer (Sign & Date) Warehouse In charge (Sign & Date)
Title:
Page 6 of 25
7.2 Manufacturing Formulae: (Original)
Product Title Batch No.
Batch Quantity Weight (Kg.): No. Of Capsule: Fill Weight
Mfg./Expiry Date Mfg./Expiry Date
Quantity
Factor/ Extra Quantity Per Weighed By Checked By
Item QC. No. Exp. Date Per Unit
Potency (%age) Batch (Kg.) (W. House) (Q.A)
(Mg)
I have confirmed that the above dispensed raw materials actives and in actives are as per approved formulation. Moreover, the
above dispensed quantity is accurate and they are within expiry.
Confirmed
By.
______________________ _________________________ __________________________________
QA. Officer (Sign & Date) Warehouse In charge (Sign & Date) Received By (Prod. Officer) (Sign & Date)
7.3 Manufacturing Formulae : (Warehouse Copy)
Batch Quantity Weight (Kg.): No. Of Tablets: Fill Weight
Mfg./Expiry Date Mfg./Expiry Date
Quantity
Factor/ Extra Quantity Per Weighed By Checked By
Item QC. No. Exp. Date Per Unit
Potency (%age) Batch (Kg.) (W. House) (Q.A)
(Mg)
Title:
Page 7 of 25
I have confirmed that the above dispensed raw materials actives and in actives are as per approved formulation. Moreover, the
above dispensed quantity is accurate and they are within expiry.
Confirmed
By.
______________________ _________________________ __________________________________
QA. Officer (Sign & Date) Warehouse In charge (Sign & Date) Received By (Prod. Officer) (Sign & Date)
Title:
Page 8 of 25
8. Mixing and Granulation:
8.1 Line Clearance before Mixing and Granulation:
8.1.1
Check for the cleanliness condition of area/Equipment and rare
8.1.2
visually clean, or the sticker of cleanliness Is pasted.
Check the differential pressure of the area is negative as compared
8.1.3
to corridor.
8.1.4
product is noticed
8.1.5 All materials of previous operations have been removed
Check the integrity of sieve, Granulator, Dryer/ Fluid Bed Dryer and
8.1.6
Mixer.
8.1.7 Check the wash water analysis report.
Review all applicable GMP Processing Area Logbook(s) and verify
that Cleaning has been performed according to Facility Cleaning
8.1.8
Procedures ( )
Date Cleaning Complete: _____________
I have confirmed the above stated requirements are fulfilled and the area is clear for
dispensing.
Confirmed By.
______________________ _________________________
QA. Officer (Sign & Date) Production Officer (Sign & Date)
8.2 Sieving Process:

Sieve the following ingredients through 40 Mesh Supervised By
Date
SS Screen Production Q.A.I
Raw Material Unit Std. Qty. Actual Qty.
Sieving Sieving
Total Time
Start Time Stop Time
8.3 Lubrication and Mixing:
8.4 Reconciliation after Mixing Process:

Gross Weight Tare Weight Net Weight Supervised By
Container #. Date
Kg. Kg. Kg. Production Q.A.I
1
Title:
Page 9 of 25
2
3
4
Total
I have confirmed that the above steps are properly followed and the above data
mentioned is accurate and absolute.
Confirmed
By
______________________ _________________________
Transfer the dry granules into the Z-mixer and add the Supervised By
Date
following ingredients and mix it for 20 minutes. Production Q.A.I
Raw Material Unit Std. Qtty. Actual Qtty.
Mixing Mixing
Total Time
Start Time Stop Time
Title:
Page 10 of 25
9. Request for Analysis:
Document No. QC/SOP/004-C Version No. 000.
Title: Request of Analysis (Purified Water/Water
Page 10 of 25
for Injection, in-Process/ Finished Products)
A. TO BE FILLED BY PRODUCTION DEPARTMENT
Title:
Department Section
Dosage Type Stage
Formula No. Product Code
Batch No./Lot No. Batch Qtty. (Kg)
Mfg. Date Exp. Date
No. of Containers No. of Packs
Machine Name Processor Name
All the Date produced on Intimation slip is as per BMR & Controlled Record. I
Statement:
have checked the Data keenly and there is no deviation.
INITIATOR
(Prod. Officer) (Sign & Date) Time
B. TO BE FILLED BY QUALITY ASSURANCE DEPARTMENT
Title:
Batch No. Batch Qtty. (Kg)
Mfg. Date Exp. Date
Sampled Qtty. Sampled Packs
Physical Inspection
S.# Observations Yes No.
1. Data produced on intimation is same as BMR/ Controlled Record.
2. Item Information on Container & on intimation is same as BMR.
3. Quantity Mentioned complies with processing Batch and is
verified.
4. Product is properly closed in containers
5. Area is properly cleaned
6. Quantity Sampled was as per sampling procedure #
Remarks:
Sampled By:
(QA. Officer)
Sign & Date Time
Analysis No:
Received By: Remarks:

(QC. Officer)
Sign & Date Time
10. Certificate of Analysis (Granules/Powder):

Title:
Page 11 of 25
Document No. QC/SOP/005-A Version No. 000.
Title: Certificate of Analysis (Report) Page 11 of 25
TITLE:
REGISTRATION NO. BATCH NO. /LOT NO.
SECTION ANALYSIS NO.
DOSAGE FORM STAGE
FORMULA NO. PRODUCT CODE
NO. OF CONTAINERS BATCH QTTY. (KG)
MFG. DATE EXP. DATE
ENV. CONDITIONS RETEST DATE
DATE RECEIVED REFERENCE SOP
SUPPLIER
OBSERVATIONS & SPECIFICATIONS
S.NO TESTS OBSERVATIONS SPECIFICATIONS REFERENCE
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
CONCLUSION
COMPLIANCE WITH YES NO RESULTS

ACCEPTANCE
FINALIZING DATE
CRITERIA
ANALYSED BY: _________________ QC MANAGER: _________________

SIGN & DATE SIGN & DATE
11. Capsule Filling Process:

11.1 Line Clearance for Capsule Filling:
11.1.1
Check the differential pressure of the area is negative as compared
11.1.2
to corridor. (Partial Pressure: 10 t0 26 Pascal)
11.1.3 Ensure the batch, documents, labels, material, powder, tablets or
Title:
Page 12 of 25
remnants of previous product.
11.1.4 Ensure “Cleaned” label is affixed on each equipment.
11.1.5
product is noticed
11.1.6 Check the wash water analysis report.
For Cleanliness, Check the areas,
1. Area under Compression Machine.
2. Area under Balances.
3. Supply Air Grills.
11.1.7
4. Return Air Grills
5. Floor, Walls, Ceiling & Drain
6. Container, Tools, Waste Bins.
7. Light & Fixtures
Review all applicable GMP Processing Area Logbook(s) and verify
that Cleaning has been performed according to Facility Cleaning
11.1.8
Procedures ( )
Date Cleaning Complete: _____________
11.2 Initial Test before Capsule Filling:

S. No. Critical Process
Response Parameter Remarks
Variable
1. Granulation
2.
Blending Fixed order of addition
Sequence of excipient
Fixed batch size
addition
Fixed, no variation of
Load blending vessel.
blending speed.
Blending time Variation of blending time
3. FILLING
Weight of capsule Fixed weight as per label
(+ 7.5 %/+ 10.0 %) claim
Locking length.
Fixed , no variation of
Capsule filling speed
filling speed.
D.T. NMT 15 Minutes
4. STRIPING/BLISTERING/COUNTING:
5. Leak test No leakage
I have confirmed that the above steps are properly followed and the above data
mentioned is accurate and absolute.
Confirmed
By
______________________ _________________________
12. In-Process Control Form During Capsule Filling:

12.1 Observed Weights:
Date Time 1 2 3 4 5 Temp. Humi Checked Verified
Title:
Page 13 of 25
dity By By
12.2 In-Process Parameters during Capsule Filling:

Machine Setting
S. # Process / Variable Observations
(Control Variables)
1 Mixing Mixing time
2 Filling Speed, locking
3 Stripping/ blistering Leak test, speed.
13. Batch Reconciliation (Filled Capsules):

Container Gross Weight Tare Weight Net Weight Supervised By
Date
#. Kg. Kg. Kg. Production Q.A.I
1
Title:
Page 14 of 25
2
3
4
Total
13.1 Yield:
Theoretical Yield(A): _______________________________ Kg.
Actual Yield (B): __________________________________ Kg.
Unaccountable Loss (A-B=C): _______________________ Kg.
%age unaccountable loss C x 100:____________________ %.
A
Specifications: Not more than 2.0 %
Note: Given explanation if the reconciliation is outside the stated limits.:

__________________________________________________________________________________
__________________________________________________________________________________
Note:
Each container must have been labeled with the Product Name, Batch No and date before collection
of tablet in them.
Each container must contain silica gel bags.
Seal and transfer the container the quarantine store.
Report any deviation from standard.
Confirmed I have confirmed that the process of capsule filling is completed, yield is calculated
By accurately. The above mentioned data is accurate and is verified.
______________________ _________________________
14. Request for Analysis for Filled Capsules:

Page 14 of 25
C. TO BE FILLED BY PRODUCTION DEPARTMENT
Title:
Department Section
Dosage Type Stage
Mfg. Date Exp. Date
Title:
Page 15 of 25
Statement:
INITIATOR
D. TO BE FILLED BY QUALITY ASSURANCE DEPARTMENT
Title:
Mfg. Date Exp. Date
Physical Inspection
Quantity Mentioned complies with processing Batch and is
8.
verified.
Remarks:
Sampled By:
(QA. Officer)
Sign & Date Time
Analysis No:

(QC. Officer)
Sign & Date Time
15. Certificate of Analysis (Filled Capsules):

Title: Certificate of Analysis (Report) Page 15 of 25
TITLE:
DOSAGE FORM STAGE
MFG. DATE EXP. DATE
Title:
Page 16 of 25
SUPPLIER
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
CONCLUSION

ACCEPTANCE
FINALIZING DATE
CRITERIA

Title:
Page 17 of 25
16. Batch Packaging Record:
16.1 Packaging Order for Primary & Secondary Packaging: (Original):
Batch Quantity Mfg./Expiry Date
Required Weighed By Checked By
Title Code No. Extra
Quantity (W. House) (Q.A)
I have confirmed that the above dispensed packaging materials are as per approved
packaging order. Moreover, the above dispensed quantity is accurate and they are within
expiry.
Confirmed
By.
_____________________ _____________________________
16.2 Packaging Order for Primary & Secondary Packaging: (Warehouse Copy):
Batch Quantity Mfg./Expiry Date
Required Weighed By Checked By
Title Code No. Extra
Quantity (W. House) (Q.A)
Title:
Page 18 of 25
I have confirmed that the above dispensed packaging materials are as per approved
packaging order. Moreover, the above dispensed quantity is accurate and they are within
expiry.
Confirmed
By.
_____________________ _____________________________
Title:
Page 19 of 25
Note:
Before Starting Blistering Process,
 Check the coding (Batch No; Mfg. & Exp. Date ) on blister pack.
 Check the sealing bubble formation of every blister.
 Remove the defective blisters.
 Send the blistered tablets on packing line for final packaging.
16.3 Over Printing Record:
Title of Product
Batch Number
Initiation Date Mfg. Date Exp. Date
Please Pick One type
 Hard Shell
Capsule
 Soft Shell Type (By Action) Selected Type
Tablet Type
Capsule 5. General
Modified-release 6. Antibiotic
capsules
7. Psychotropic
8. Other
Quantity Batch Size No. of Tablets (App.)
Received No of
Final Weight
Tablets (App.)
YES NO.
Complete signed & Brand Name Mfg.Lic. No.

approved specimens Composition Reg. No.
is attached. Address Approved MRP.
Precautions Mfg. Date
Text English/Urdu Exp. Date
Deviation Observed
16.4 Responsible Person:

I have confirmed that the above dispensed packaging materials and over printing data is accurate.
Pkg.
Supervisor (Sign & Date):_______________ Production Officer (Sign & Date):_________________
QA Officer (Sign & Date):____________________ Production Manager (Sign & Date):________________
16.5 Online Inspection:

General Appearance Observed By
Over Pack
Date Time Sealing Leaflet Production QA.
Printing Carton Blister Size
Officer Officer
Title:
Page 20 of 25
16.6 Reconciliation of Packaging Components:

Quantity Rejected Allowable
Qty.
S.# Items Units Wastage
Received Used Unit % age Returned
(%age)
1.
2.
3.
Title:
Page 21 of 25
4.
5.
6.
7.
8.
9.
10.
17. Material for Destruction/Return:
S.# Items Units Quantity Percentage

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
I have confirmed that the above data is accurate and is verified.
Confirmed
By.
___________________________ _____________________________
Production Officer (Sign & Date) Production Manager (Sign & Date)
18. Yield Statement:

Manufacturing
Theoretical Yield Actual Yield Variance (C) %age Variance
Remarks
(A) (B) (A-B) (Kg) C/A X 100
Final Mix
Compressed Tab.
Coated Tablets
Title:
Page 22 of 25
Objective Compression Weight (Log sheet) ____________________________________
Reworking Left:_______________________________________________________________
Partial transfer, if any (Sales): ______________________________________________________
Theoretical Yield = Batch size(kg) x1000x1000  No of Tablets

Objective Compression Weight (mg)
Total unit =
Yield % (Sale) = Total Unit x100

Theoretical Yield
Given an explanation if the reconciliation is outside the stated limit.
I have confirmed that the above data is accurate.
Production Officer (Sign & Date):_______________ Production Manager (Sign & Date):_____________
QA Officer (Sign & Date):______________________ QA Manager (Sign & Date):____________________

Title:
Page 23 of 25
19. Request for Analysis for Finished Product:
Page 23 of 25
E. TO BE FILLED BY PRODUCTION DEPARTMENT
Title:
Department Section
Dosage Type Stage
Mfg. Date Exp. Date
Statement:
INITIATOR
F. TO BE FILLED BY QUALITY ASSURANCE DEPARTMENT
Title:
Mfg. Date Exp. Date
Physical Inspection
Quantity Mentioned complies with processing Batch and is
14.
verified.
Remarks:
Sampled By:
(QA. Officer)
Sign & Date Time
Analysis No:

(QC. Officer)
Sign & Date Time
20. Certificate of Analysis (Finished Product):

Title:
Page 24 of 25
TITLE:
DOSAGE FORM STAGE
MFG. DATE EXP. DATE
SUPPLIER
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
CONCLUSION

ACCEPTANCE
FINALIZING DATE
CRITERIA

Title:
Page 25 of 25
21. Finished Product Transfer Slip:
Product Name: _______________________ Batch #.__________________ Batch Size:______________
Mfg. Date : _______________________ Expiry Date:____________ Date:_________________
Qty. Transferred
Pack Total Qtty. Received
Date Time Master Status Issued By
Size Loose Pack Transferred By
Carton
Total Quantity transferred on Completion of Batch:____________________
Pack Size:______________________
Sample to Q.C _________________
Total Batch Qty:__________________
______________________ _______________________ ____________________

Warehouse In-charge Production Manager QA. Manager

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Document No. WB/PD/SOP/002-B Version No. 000.

Issue Date 25/03/2019 Effective Date 01/04/2019

 Hard Shell Capsule

Quantity Batch Size No. of Capsules (App.)

2. Product Batch Manufacturing Record Issuance:

6. Instructions for Production Department:

8.2 Sieving Process:

8.3 Lubrication and Mixing:

8.4 Reconciliation after Mixing Process:

Received By: Remarks:

10. Certificate of Analysis (Granules/Powder):

COMPLIANCE WITH YES NO RESULTS

ANALYSED BY: _________________ QC MANAGER: _________________

11. Capsule Filling Process:

11.2 Initial Test before Capsule Filling:

12. In-Process Control Form During Capsule Filling:

12.2 In-Process Parameters during Capsule Filling:

13. Batch Reconciliation (Filled Capsules):

Note: Given explanation if the reconciliation is outside the stated limits.:

14. Request for Analysis for Filled Capsules:

Received By: Remarks:

15. Certificate of Analysis (Filled Capsules):

COMPLIANCE WITH YES NO RESULTS

ANALYSED BY: _________________ QC MANAGER: _________________

Complete signed & Brand Name Mfg.Lic. No.

16.4 Responsible Person:

QA Officer (Sign & Date):____________________ Production Manager (Sign & Date):________________

16.5 Online Inspection:

16.6 Reconciliation of Packaging Components:

17. Material for Destruction/Return:

S.# Items Units Quantity Percentage

18. Yield Statement:

Partial transfer, if any (Sales): ______________________________________________________

Theoretical Yield = Batch size(kg) x1000x1000  No of Tablets

Yield % (Sale) = Total Unit x100

Given an explanation if the reconciliation is outside the stated limit.

I have confirmed that the above data is accurate.

QA Officer (Sign & Date):______________________ QA Manager (Sign & Date):____________________

Received By: Remarks:

20. Certificate of Analysis (Finished Product):

COMPLIANCE WITH YES NO RESULTS

ANALYSED BY: _________________ QC MANAGER: _________________

Product Name: _______________________ Batch #.__________________ Batch Size:______________

Mfg. Date : _______________________ Expiry Date:____________ Date:_________________

Total Quantity transferred on Completion of Batch:____________________

Sample to Q.C _________________

Total Batch Qty:__________________

______________________ _______________________ ____________________

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ANALYSED BY: _ QC MANAGER: _

ANALYSED BY: _ QC MANAGER: _

QA Officer (Sign & Date):____ Production Manager (Sign & Date):

QA Officer (Sign & Date):__ QA Manager (Sign & Date):

ANALYSED BY: _ QC MANAGER: _

Product Name: _______ Batch #. Batch Size:

Mfg. Date : _______ Expiry Date: Date:_

__________ _ __________