Department: Quality Assurance QRM No.

:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

QUALITY RISK ASSESSMENT

(FAILURE MODE EFFECTS ANALYSIS)
QUALITATIVE RISK MANAGEMENT)
OF
MANUFACTURING OF ORAL SOLID
DOSAGE FORM
1. APPROVAL

Prepared By:

Department Name Designation Signature Date

Quality Assurance

Reviewed By:

Department Name Designation Signature Date

Production

Quality Control

Microbiology

Engineering

Approved By:

Department Name Designation Signature Date

Quality Assurance

Page 1 of 37
Department: Quality Assurance QRM No.:

SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

TABLE OF CONTENTS

Sr. No. Content Page No.

1. APPROVAL 1
2. PURPOSE 3
3. SCOPE 3
4. RESPONSIBILITIES 3
5. ABBREVIATION 4
6. CROSS FUNCTIONAL TEAM 4
7. REFERENCE DOCUMENT 4
8. RISK MANAGEMENT TOOLS 5
9. RISK ANALYSIS SCALE 5-35
10. CONCLUSION 36
11. RISK COMMUNICATION 36
QUALITATIVE SCALE FOR SEVERITY, OCCURRENCE AND
12. 37
DETECTION

Page 2 of 37
Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

2. PURPOSE
The purpose of this document is to provide a procedure to identify the failure modes / process risks
from Receiving of Materials to dispatch of Finished Goods, verify existing controls and provide
recommendations for mitigation of residual risks, if any.
This risk assessment shall emphasize on potential risks of contamination and cross-contamination of
product during receiving, storage, processing and dispatch of solid oral dosages form.
3. SCOPE
This QRM document is applicable to Risk assessment of oral solid dosage form manufacturing and packing
process.

4. RESPONSIBILITIES
Department / Description
Function
Quality Assurance  To provide leadership and adequate resources for QRM as an ongoing process
 To assure that QRM process is defined, deployed and reviewed
 To select multi-disciplinary team (QRM Team) of qualified personnel from
concerned stakeholders on need base
 To communicate, promote and co-ordinate QRM across various functions and
departments
 To evaluate the adequacy and completion of risk management report
 To ensure appropriate CAPAs are recommended and implemented
 To review and approve Risk Management Reports
CFT / QRM Team  To adhere QRM Standard Operating Procedure
 To conduct a risk assessment by identification, analysis, evaluation and
mitigation of potential risk
 To evaluate risks and its impact and determine which one should be controlled
and which ones can be accepted
 To recommend and implement adequate control measures for risk reduction
 To consider the impact of risk findings on related or similar products and/or
processes
 To inform output/result of QRM process to site management (QA Head and
Unit Head), ensuring that significant risks are immediately escalated
 To ensure recommended CAPAs initiated, monitored and implemented timely
 To ensure that the adequate training on the subject is available to team members
and training records are accessible

Page 3 of 37
Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

5. ABBREVIATION

QA Quality Assurance EHS Environment, Health and safety

QC Quality Control HRA Human Resource and Admin
QRM Quality Risk Management BMR Batch Manufacturing Record
FMEA Failure Mode Effect Analysis BPR Batch Packing Record
CFT Cross functional team SS Stainless steel
RPN Risk Priority number SOP Standard operating procedure

6. CROSS FUNCTIONAL TEAM

Sr. No. Name Department Designation

7. REFERENCE DOCUMENT

Title
Quality Risk Management
Cleaning of production area
Cleaning of area, equipments and accessories
Management of accessories
Control and monitoring of cross contamination
Entry Exit procedure to manufacturing and primary packing area
Entry Exit procedure to sampling and dispensing area
Usage of in process label
Receipt, Verification and storage of Raw material / packing material & miscellaneous
Dispensing of raw and Packing Material
Handling of Rejected raw and packing material
Operation and Cleaning of dispensing Booth
Finished goods Dispatch
Finished Good receipt and storage
Line clearance for Dispensing, Manufacturing, and Packing area
Handling of interruption in manufacturing and packing area
Handling of interruption in manufacturing area
Procedure of preventive maintenance of air handling unit

Page 4 of 37
Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

8. RISK MANAGEMENT TOOLS

FMEA- Quantitative Risk Management

9. RISK ANALYSIS SCALE

Severity – Rating
Value (S) Severity
5 Catastrophic, Can cause serious adverse health consequence including death of the patient
4 Critical, May cause permanent medically irreversible adverse health condition
3 Moderate, May cause temporary medically reversible adverse health condition
2 Marginal, May cause discomfort but not likely to cause adverse health consequences
1 Negligible, May cause temporary discomfort

Probability – Rating
Value (P) Probability
5 Almost certain, Failure is almost inevitable
4 Likely, Repeated Failures
3 Possible, Occasional Failures
2 Unlikely, Relatively few failures
1 Rare, Failure is unlikely

Detectability – Rating
Value (D) Detectability
5 Very Low, the risk will not be detected
4 Low, the risk is unlikely to be detected
3 Moderate, a potential risk may be detected
2 High, has a good chance of detecting the risk
1 Very High, will almost certainly be detected

Risk Classification

Severity (S) Negligible Marginal Moderate Critical Catastrophic

Probability (P) (1) (2) (3) (4) (5)
Almost certain (5) 5 10 15 20 25
Likely (4) 4 8 12 16 20
Possible (3) 3 6 9 12 15
Unlikely (2) 2 4 6 8 10
Rare (1) 1 2 3 4 5
Risk class: Minor (1- 4), Risk class: Major (5 - 10) and Risk class: Critical (12 - 25)

Page 5 of 37
Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

Risk Priority Number chart is depicted below:

Risk is acceptable, routine procedure exists to address risk (1 - 20)

Risk needs review of existing controls and additional applicable mitigation measures to
minimize the risk (24 - 50)
Risk is unacceptable, immediate action must be taken to mitigate (60 - 125)

Risk Class Risk Priority Number

25 25 50 75 100 125
20 20 40 60 80 100
RISK EVALUATION SCORE

16 16 32 48 64 80
15 15 30 45 60 75
12 12 24 36 48 60
10 10 20 30 40 50
9 9 18 27 36 45
8 8 16 24 32 40
6 6 12 18 24 30
5 5 10 15 20 25
4 4 8 12 16 20
3 3 6 9 12 15
2 2 4 6 8 10
1 1 2 3 4 5
DETECTABILITY 1 2 3 4 5

Page 6 of 37
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
FMEA-Quantitative Risk Management

Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

1.0 Material Management

1.1 Unit Operation: (Material Receipt and Handling)
1.1.1 Material Material Product Inadequate 5 Potential impact 1 No such deviation  Adequate procedure for loading and unloading of materials
Receipt contamina contamination procedure on product reported from Nov- from vehicle is in-place.
tion in the Material for loading quality 2020 to Till date.  Material inward process at material receiving bay is also
Vehicle rejection and un- attributes. Hence occurrence is defined in above mentioned SOP.
during loading Hence severity rated as 1.  SOP provides instruction for verification of documents by
transportat is rated as 5. security person and entry in Security register and then
ion security stamp is applied at the back of invoice.
 Materials are procured from approved vendor only.
Transportatio 5 Potential impact 1 No such deviation  Vehicle Inspection is carried out before unloading of
n of on product reported from Nov- material and following points are ensured:
Hazardous quality attributes. 2020 to Till date.  Vehicle is properly covered and cleaned
chemicals Hence severity is Hence occurrence is  Only pharmaceutical material are handled
and material rated as 5. rated as 1.  No spillage / expose of the materials
in same  No contamination with other material
vehicle.  Intactness/spillage of the container and cleanliness of
material container
 If any discrepancy found, the same is informed QA. Afte
getting QA decision, further activity is performed.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Material Material Canopy not 5 Potential impact 1 No such deviation  Canopy is available on loading/unloading bay to protec
become rejection available on on product quality reported from Nov- the material during rainy season
wet during Material loading / attributes. Hence 2020 to Till date.
unloading/ damaged unloading bay severity is rated as Hence occurrence is
loading to protect the 5. rated as 1.
due to rain material
during
unloading /
loading in
rainy season
Incorrect Receipt of Wrong 5 Potential impact 1 No such deviation  During unloading, material and documents are verified as
Material unapproved / material on product reported from Nov- per respective format and following points are ensured:
Receipt substandard supplied by quality 2020 to Till date.  Vendor with approved vendor list
material may vendor and attributes. Hence Hence occurrence is  Material Code and Description
impact Wrong severity is rated rated as 1.
 Supplier Name
product material as 5.
quality. delivered by  Vendor Lot / Batch No.

May lead to transporter.  Manufacturer Name.

contamination  Batch number as per COA vs actual on container label.
and mix-up  Mfg. date and Expiry date.
of one  COA
consignment  Verification is carryout as per checklist for Material receip
to other.
 If any discrepancy found, the same is informed to
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Incorrect Material Short / Excess 3 Low impact on 1 No such deviation  Material receipt is regulated by weighing as per respective
Quantity shortage or quantity send Process and reported from Nov- format.
received excess has by Vendor Product Quality. 2020 to Till date.  Recording of the gross weight of container is done in the
(Shortage impact on Hence severity is Hence occurrence is respective format.
or excess) business rated as 3. rated as 1.
continuity
Incorrect / It may impact Wrong 5 Potential impact 1 No such deviation  Physical verification of the material has been done a
Missing / the identity, product label on product reported from Nov- receipt stage as per SOP.
Uneven / quality and from vendor quality attributes. 2020 to Till date.  All container labels are verified during receipt of the
Partial integrity of end Hence severity is Hence occurrence is material and details are recorded in Material receip
label material / rated as 5. rated as 1. observation report.
product.
Material
Mix- up
1.1.2 Storage Incorrect contamination Inadequate 5 Potential impact 1 No such deviation  Separate area for rejected raw/Quarantine area / Approved
(Ware- storage / cross- procedure for on product reported from Nov- RM area and packing material and keys of that area
house) container contamination segregation quality attributes. 2020 to Till date. available with store head or designee.
location by Mix-up Hence severity is Hence occurrence is  Physical segregation is done for storage of materials. One
and rated as 5. rated as 1. material is stored on one pallet. Multiple lots / materials
improper can be stored on the same pallet by using the partition for
segrega- segregating the different lots.
tion
Spillage 5 Potential impact 1 No such deviation  The concern person is trained on the relevant SOP for
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

leading to
formation of
impurities
during storage
and its
introduction
in the
formulation.
1.1.3 QC Incorrect Incorrect Due to 5 Potential impact 1 No such deviation  Warehouse person informs QC for sampling by
Samp- sampling sampling may wrong on product reported from Nov- providing material test request.
ling of raw result into information quality 2020 to Till date.  Sampling activity is carried out by trained Quality
(Ware- material incorrect data on vendor attributes. Hence Hence occurrence is Control personnel as per SOP.
house) and analysis and COA and severity is rated rated as 1.  Sampling is performed by QC as per specified test in
packing reporting. MRV. as 5. specification and sampling plan.
materials Sample may Inadequate  Scanning of Material Detail Labels for correct material
(different not be procedure. selected for sampling against the MRV and Verification of
material representative Untrained container labels by sampler for correctness of material
sampled / of that staff. details.
different specific batch  Also QC personnel affix “SAMPLED” label on each
batch of and may sampled containers.
same impact
material product
sampled) quality
leading to
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

2.1 Issuance Insufficie Productivity/ Raw 2 Minimal impact 1 No such deviation  Warehouse receives BMR/BPR and checks and issue
of Raw nt raw Business Loss materials on Process and reported from Nov- materials as per BMR/BPR.
Material materials stock not Product Quality. 2020 to Till date.  Materials are allocated as per FEFO in and only approved
s from or Stock maintained Hence severity Hence occurrence is materials issued against as per SOP “Dispensing of raw
Store to unavailabi is rated as 2. rated as 1. material and packing material”.
dispensi lity  Raw materials and packing materials stock is maintained
ng area by warehouse department.
Wrong Mix-up. Inadequate 5 Potential impact 1 No such deviation  Store receives BMR/BPR. Store personal checks and
material Batch failure. procedure for on product reported from Nov- issue materials as per BMR/BPR.
issuance material quality 2020 to Till date.  SOP on “Dispensing of raw and packing material” is in-
and verification attributes. Hence occurrence is place to explain the procedure of issuance of Raw material
transfer Hence severity rated as 1. and packing material.
from is rated as 5.  Verification of each container/Pack for its material code,
Store material description, batch number and quantity on
material detail label being done during collection of the
material as per BMR.
2.2 Entry in Improper contamination Inadequate 5 Potential impact 1 No such deviation  SOP for gowning practice before entering in dispensing
Dispensi Gowning of drug gowning on product reported from Nov- area is in-place “Entry/Exit Procedure for sampling and
ng Area (Boiler product. procedure for quality 2020 to Till date. Dispensing area”) and personnel working in dispensing /
suit, Head May have entry in attributes and Hence occurrence is store area are trained on the SOP.
gear cap, impact on dispensing patient safety. rated as 1.  Visual pictorial display of gowning and de-gowning
Facemask personnel area. Hence severity procedure is displayed as per SOP.
and Shoe safety. Use of is rated as 5.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

dust particle to bottom mounted return air riser.

 Operator wears PPEs which ensures minimal impact on
operator safety.

Usage of Product Procedure 5 Potential impact 1 No such deviation SOP for Usage and cleaning of Ancillary items,

uncleaned contamination not available on product reported from Nov- Container and Utensil is available for respective area.
dispensing / cross- / Inadequate quality attributes 2020 to Till date.  Cleaning of vendor container from outside with clean lint
tool/ contamination procedure and patient Hence occurrence is free cloth prior to dispensing activity is performed as per
utensil by Retention safety. rated as 1. procedure.
and Mix-up Hence severity is  After dispensing of each material, used scoop is kept
rated as 5. in separate polyethylene bags with “To be cleaned” label
and transferred to washing area for cleaning.
 Before dispensing, availability of adequate number of
cleaned utensils is ensured.
 Before dispensing visually inspection and line clearance
is done.
 Every ancillary item has unique ID Number for
traceability.
dispensing Disturbed Booth 5 Potential impact 1 No such deviation  SOP for dispensing of raw material is in-place
outside laminarity devoid of on product reported from Nov- „Dispensing of Raw and packing Materials” and
the safe leading to safe working quality attributes 2020 to Till date. “Operation and Cleaning of dispensing booth” which is
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

dispensing It may lead Improper 5 Potential impact 1 No such deviation  Verification of material before dispensing done.
of Wrong to deviation / verification on product reported from Nov-  Personnel involved in dispensing are trained on the
Material OOS result of material quality attributes 2020 to Till date. respective SOP before work allocation.
Product before and patient Hence occurrence is  Material is dispensed as per BMR instruction and same is
contamination dispensing safety. rated as 1. recorded in respective BMR.
/ cross and during Hence severity is  Weight verification of dispensed material is performed
contamination dispensing rated as 5. before commencement of the unit operation.
by Mix-up Untrained  Area / Machine line clearance performed by production
staff and approved by QA as per SOP.
More than  After dispensing, dispensed material label is verified for
one material no., material name, and quantity in BMR, B. No.
container of with BMR and booth ID no. by manufacturing and label
different affixed in respective BMR.
materials  Before start of manufacturing process, dispensed materials
taken for batch / lot-wise physically verified by production.
dispensing at
a time
Usage of 5 Potential impact 1 No such deviation  Balance are calibrated and verified as per SOP before start
un- on product reported from Nov- of dispensing and also capacity-wise balance is used for
calibrated quality attributes 2020 to Till date. dispensing of materials.
weighing and patient Hence occurrence is  Operating range is mentioned in respective weighing
balance safety. rated as 1. balance verification format.
Hence severity is
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

3.0 Handing of Material Rejection

3.1 Material Improper Mix-up Inadequate 5 Potential impact 1 No such deviation  SOP for “Handling of Rejected raw and Packing
rejection Handling May impact movement of on product quality reported from Nov- Material” is available.
of rejected on product rejected attributes and 2020 to Till date.  Procedure for Handling of Rejected Raw and Packing
materials quality. material. patient safety. Hence occurrence is Materials as per below:
(RM/PM/ Worker/ Hence severity is rated as 1.  If the material gets rejected, QC department informs
Finished Employee rated as 5. regarding rejection and affixes rejected labels on the
Goods) safety rejected containers.
 Store person transfer the rejected materials to the rejected
material storage area. The room is locked and key is with
QA Department.
 On receipt of instructions from the HO purchase team
regarding return of materials to vendor or destruction of
the materials, follow as directed.
 Rejected Printed material is not returned; it is destroyed
at site only.
 Instruction given in the SOP to verify the name of
material, material code, Batch No. & quantity of material
to be destroyed.
 Verification of the material is done by QA.
 Cut, drill and shred the printed packaging material as per
the possibility during destruction.
 Destructed material kept in the polybag with tied
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

4.0 Manufacturing Process

4.1 Perso- Unhealthy Potential Procedural 5 Potential impact 2 Occurrence may Procedure is in-place for pre-employment medical

nnel person in impact on control not in- on product quality happen but no such examination before joining all personnel and during
production product place attributes and deviation reportedservice; every employee undergoes for routine / annual
activity quality patient safety. from Nov- 2020 to medical check-ups to ensure healthiness or fitness.
attributes. Hence severity is Till date. Hence SOP is in- place to maintain personal hygiene for all the

Microbial rated as 5. persons entering into production area.

occurrence is rated as
contamination 1.  Procedure for Self-health declaration for visitors‟ in-

of drug place.
product.  If any person suffering with any contagious disease, at
first him / herself report it to his / her immediate superior
to entering manufacturing area.
 Any person availing leave due to illness, need to inform
the respective Department Head and HR department.
 The OHC in-charge verifies the reported sickness.
 In case of certain diseases a person is advised to take rest
by the doctor. He may do so by availing sick leave and can
resume duty after fitness approval by the doctor.
 cGMP training is provided to all new joiners and annually
refresher training is imparted to all employees.
4.2 Entry in Improper contamination Inadequate 5 Potential impact 1 No such deviation  SOP for gowning practice before entering in
producti Gowning of drug gowning on product quality reported from Nov- manufacturing area is in- place and personnel working in
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

multiple
processing
area

4.3 Environ Environme May have Area AHU 5 Potential impact 2 No such deviation  Document of HVAC qualification is in-place.
mental ntal impact on system not on product quality reported from Nov-  Adequately designed and Qualified AHU are installed
conditio condition quality of qualified. attributes and 2020 to Till date but for maintaining desired environmental conditions of
n not drug product. patient safety. considering probability area. AHU system is re-qualified as per protocol.
(Temp. maintained May lead to Hence severity is of occurrence is rated as  SOP for Operation of Air Handling Unit is in-place.
2.  PM of AHU is done as per SOP and concerned staff
RH) of / product rated as 5.
Raw monitored. degradation. is trained on procedure.
material  SOP for monitoring of Temperature and %RH during

staging manufacturing stages and storage is in- place.

area /  Monitoring of Area Differential Pressure, inside the

quaranti Plant” is done as per SOP. If any excursion observed

ne area / in the area conditions are handled through the standard
Processi procedure.
 HVAC system is installed to maintain and control the
ng area.
temperature, %RH and differential pressure of process
area. The HVAC system is qualified.
Use of Non- 4 Potential impact 1 No such deviation  Calibration planner is available to carry out the
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

quaranti frequency.
ne area/  In case the differential pressure is found out of limit
Processi during processing, stop the process activity and close
ng area. the product container. Notification is to be raised.
Process is started after rectification.

Use of Non- 5 Potential impact 1 No such deviation  SOP for Calibration of instrument with planer is
calibrated on product quality reported from Nov- available
differential attributes. Hence 2020 to Till date.  Calibrated Differential Pressure gauges are installed
pressure severity is rated as Hence occurrence is and periodically recalibrated as per recalibration
measuring 5. rated as 1. planner.
gauge
4.5 Area Insects Product Inadequate 5 Potential impact 1 No such deviation  SOP for “Pest control” with controls like Disinfection
Design entry in contamination control on product quality reported from Nov- treatment, Pest-o-Flash, Glue Traps and Rodent Baits.
process measures for attributes. Hence 2020 to Till date.  Procedure, schedule and frequency is defined for
areas access to pest, severity is rated as Hence occurrence is treatment of pest, rodent, flies, insects.
rodents, flies 5. rated as 1.  Annexure of Drawings in- place and location defined for
and insects treatment and pest control service provider follows the
into the procedure.
production
facility.
4.6 Building Periodic contamination Procedural 5 Potential impact 1 No such deviation  SOP for "Building Maintenance" provides instructions
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

4.7 Equip- Rough or Cross- Use of non- 5 Potential impact on 1 No such deviation  Procedure for qualification (DQ/IQ/OQ/PQ) of
ment un- contamination qualified product quality reported from Nov- Equipments is in-placed.
Design polished by Retention equipment. attributes. Hence 2020 to Till date.  Design of equipment is verified and equipment is
machine of previous severity is rated as Hence occurrence is qualified before routine usage.
contact product 5. rated as 1.  Usage of GMP model equipment with contact part of
surface S.S. 316 grade material and their surfaces are smooth,
Crevices/ free from pitting, scratches, abrasions, rusts etc.
Ledges on  During the Cleaning Validation Hard to clean area are

machine identified to prevent the Carryover of one product to

contact next product.
part
Inadequate 4 Potential impact on 1 No such deviation  Design of equipment is verified and equipment is
design/ space product quality reported from Nov- qualified before routine usage.
of equipment attributes. Hence 2020 to Till date.  Usage of GMP model equipment with contact part of
severity is rated as Hence occurrence is S.S. 316 or food grade material and their surfaces are
4. rated as 1. smooth, free from pitting, scratches, abrasions, rusts etc.

Procedure for 4 Potential impact on 1 No such deviation  Preventive maintenance of all equipment is performed as
preventive product quality reported from Nov- per schedule mentioned in preventive maintenance SOP
maintenance attributes. Hence 2020 to Till date. and checklists of respective equipment.
not available severity is rated as Hence occurrence is
4. rated as 1.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Improper 5 Potential impact on 1 No such deviation  Status label of cleaned drums / containers (HDPE / SS)
labelling of product quality reported from Nov- used for storage of materials is affixed on container and
storage attributes. Hence 2020 to Till date. signed.
container. severity is rated as Hence occurrence is
5. rated as 1.

4.9 General Uncleaned Uncleaned Inadequate 5 Potential impact on 1 No such deviation  SOP for area cleaning is in-place.
(All processing area / cleaning and product quality reported from Nov-  Cleaning of the area is carried out on daily basis using
Proce- area/ Equipment verification attributes. Hence 2020 to Till date. disinfectant solution as specified in SOP.
ssing Equipment and Drain procedure. severity is rated as Hence occurrence is  SOPs for cleaning of respective equipment are in-place.
cubicle/ may lead 5. rated as 1.  Visual inspection of equipment is carried out after
Equipm contamination cleaning by Production and Quality Assurance.
ent‟s/ / cross- Moreover, equipment cleanliness is verified during line
Area) contamination clearance as per SOP.
, Microbial
growth
Hold time of 5 Potential impact on 1 No such deviation  SOPs for cleaning of respective equipment are in-place.
Uncleaned product quality reported from Nov-  Hold time for Dirty Equipment is for 24 hours. If
equipment‟s attributes. Hence 2020 to Till date. holding time of Dirty Equipment exceeds more than 24
not defined severity is rated as Hence occurrence is hours then equipment is subjected for extensive cleaning.
5. rated as 1.  Instruction is mentioned in each SOP to ensure the
cleaning of uncleaned equipment within 24 hours.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

to be carried out.

Cleaning 5 Potential impact on 1 No such deviation  SOP for Cleaning of sieve / screen is in-placed. During
procedure of product quality reported from Nov- line clearance visual inspection is performed for
sieve / screen attributes. Hence 2020 to Till date. cleanliness of sieve/ screen.
not in-place severity is rated as Hence occurrence is
5. rated as 1.

Wrong Change in Sieve size not 5 Potential impact 1 No such deviation  Sieve size for sifting of raw material is defined in
sieve used sieve size defined in on product quality reported from Nov- respective BMR.
for sifting may have BMR. attributes. Hence 2020 to Till date.  The sifter sieve identity is checked and verified by
of impact on Sieve size severity is rated as Hence occurrence is production before use and it is recorded in BMR.
dispensed PSD of raw not checked 5. rated as 1.
raw material before taking
materials which may it for sifting
affect the process.
finished
product
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

4.12 Drying Use of Cross- No set-up 5 Potential impact on 1 No such deviation  SOP for operation of drying equipment is in-place.
(Set-Up) wrong contaminati identification product quality reported from Nov-  SOP defines procedure for receipt, usage, cleaning and
set-up on by attributes. Hence 2020 to Till date. drying of vacuum tray dryer.
product severity is rated as Hence occurrence is
mix- up 5. rated as 1.

Usage contamination Procedure 5 Potential impact on 1 No such deviation  SOP for cleaning and operation is in- place.
of / Cross- not product quality reported from Nov-  Visual inspection is carried out after cleaning.
unclean contamination available / attributes. Hence 2020 to Till date.  Cleaning and drying record is maintained and details
tray by Retention Inadequate severity is rated as Hence occurrence is are recorded in the logbook.
of product procedure 5. rated as 1.  Additionally, Checked physically for cleanliness during
line clearance activity.
4.13 Drying Improper It may lead Wrong drying 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for vacuum
drying of increasing parameter set product quality reported from Nov- tray dryer is in-place.
wet level of in machine. attributes. Hence 2020 to Till date.  Drying process parameters are defined in respective
granules Related severity is Hence occurrence is BMR.
Substances rated as 1.  % LOD is verified as end point detection for drying
(RS) (i.e.: stage.
Impurities)  Drying process parameters are set as per instruction
due to over mentioned in respective BMR.
drying and  FG analysis procedure is in-place prior to batch

thus release
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

4.15 Sifting Improper It may have Sifting 5 Potential impact on 1 No such deviation  Sifting is done as per instructions mentioned in
of sifting of impact on instructions product quality reported from Nov- respective BMR using specified sifter and sieve size as
milled dried / PSD of not defined attributes. Hence 2020 to Till date. defined in BMR.
granules milled granules, severity is rated as Hence occurrence is
or dried granules granules flow. 5. rated as 1.
granules Product
quality
Wrong sieve 5 Potential impact on 1 No such deviation  Sieve size is checked by production and verified by QA
size usage product quality reported from Nov- during line clearance activity.
attributes. Hence 2020 to Till date.  Sieve size is verified during batch execution and sieve
severity is rated as Hence occurrence is size is recorded in respective BMR.
5. rated as 1.

Damaged 5 Potential impact on 1 No such deviation  Before and after sifting activity, screen / sieve integrity
sieve / screen product quality reported from Nov- is checked and recorded in BMR.
usage attributes. Hence 2020 to Till date.  If sieve / screen damage observed after milling, inform
severity is rated as Hence occurrence is to supervisor and concerned QA person for taking
5. rated as 1. appropriate action.

4.16 Milling Generation contamination Screen 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for multi
of dried of foreign by mechanical damage due to product quality reported from Nov- mill is in-place. SOPs provide instructions for machine
granules particle transfer improper attributes. Hence 2020 to Till date. Set-Up and operation.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Wrong Screen 5 Potential impact on 1 No such deviation  Screen size is checked by production and verified by QA
used for product quality reported from Nov- during line clearance activity.
milling attributes. Hence 2020 to Till date.  Screen size is defined in respective BMR and the same is
severity is rated as Hence occurrence is verified during batch execution and screen size is
5. rated as 1. recorded in BMR.

4.18 Milling Improper Cross- Established 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for multi mill
(Clean- cleaning of contamination Cleaning product quality reported from Nov- is in-place. SOPs provide instructions for machine
ing) equipment by retention, procedure not attributes. Hence 2020 to Till date. cleaning.
leading to in-place severity is rated as Hence occurrence is  Visual inspection of equipment is carried out after
carryover of 5. rated as 1. cleaning by production and QA. Moreover, equipment
API residue to cleanliness is verified during line clearance as per SOP.
next batch.  Trained personnel are involved in cleaning activity.
 Cleaning verification done for each batch of each
product.
4.19 blending Wrong contamination Inadequate 5 Potential impact on 1 No such deviation  Intra-granular materials are verified for correctness prior
and material / Cross- material product quality reported from Nov- to blending and lubrication stage by verifying Material
Lubrica- used for contamination verification attributes. Hence 2020 to Till date. Detail Label) against BMR.
tion blending of product by procedure severity is rated as Hence occurrence is  Similarly Extra granular materials are verified for
(Set-Up) and Mix- up 5. rated as 1. correctness prior to blending and lubrication stage by
lubrication verifying Dispensed Material Label against BOM
specified in BMR.
Spillage / Cross- Manual 5 Potential impact on 1 No such deviation  Loading is done through manual transfer system.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

4.20 blending Under or Potential Wrong time 5 Potential impact 1 No such deviation  SOP for Operation and cleaning procedure for blender is
and Over impact on and RPM on product quality reported from Nov- in-place.
Lubricat blending Granules selected in attributes. Hence 2020 to Till date.  Process validation is carried out for individual product
ion & flow, blender. severity is rated as Hence occurrence is and blending parameters are verified. After successful
(Operati Lubricatio uniformity of 5. rated as 1. completion of process validation, blending stage
on) n mixing & parameters are recommended for commercial
product manufacturing and included in BMR.
quality  Blending time and blender speed (RPM) is set as per

attributes. instruction mentioned in respective BMR.

4.21 blending Improper Cross- Established 5 Potential impact on 1 No such deviation  SOP for operation and cleaning procedure for blender” is
and cleaning of contamination Cleaning product quality reported from Nov- in-place. SOPs provide instructions for machine
Lubricat equipment by retention, procedure not attributes. Hence 2020 to Till date. cleaning.
ion leading to in-place severity is rated as Hence occurrence is  Visual inspection of equipment is carried out after
(Clean- carryover of 5. rated as 1. cleaning by production and QA. Moreover, equipment
ing) API residue to cleanliness is verified during line clearance as per SOP.
next batch.  Cleaning validation done for worst case product.
4.22 Compre Wrong It may lead to Improper 5 Potential impact on 1 No such deviation  SOP for Punches and Dies is in-place.
ssion change change in identification product quality reported from Nov-  Procedure for Procurement, Receipt, Inspection, Storage,
parts description/ and storage of attributes. Hence 2020 to Till date. Control Issuance, Usage, Cleaning, Polishing and
issuance appearance of change parts severity is rated as Hence occurrence is Disposal of Tablet Tooling is defined in the SOP.
and usage product and 5. rated as 1.  SOP provides instructions for storage and management
may lead to of change parts in designated storage cabinet.
cross-
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

compressi
on.
Improper Impact on Inadequate 5 Potential impact on No such deviation  SOP for Operation and cleaning procedure for tablet
setting of product instruction in product quality reported from Nov- compression machine” is in-place which provides
compressi quality BMR / SOP attributes. Hence 1 2020 to Till date. instructions for setting of dies and punches and other
on attributes. for severity is Hence occurrence is machine components.
machine compression rated as 1.  Compression machine test run, functioning &
machine verification test is carried out before startup.
setting
In-Process Impact on Inadequate 5 Potential impact on 1 No such deviation  SOP for In-process checks for various production
failures at product machine product quality reported from Nov- activities” in-place. SOP for compression machine
compressi quality setting attributes. Hence 2020 to Till date. operation and setting is in-place.
on stage attributes. Improper severity is rated as Hence occurrence is  Set-up checks are carried out as defined in respective
(Weight process 5. rated as 1. BMR.
variation, parameters  The process parameters along with results of in- process
Thickness, check are recorded in BMR.
Hardness,  Process validation was performed and meets its
Friability, predetermined specifications.
DT etc.)  Process validation will be perform during introduction of
new product at facility and after meeting acceptance
criteria, proceeded for commercial batches), hence
validated process parameters are recommended for
commercial batch Stage wise BMR is reviewed by
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Lubrication attributes. Hence 2020 to Till date.  (Description) of Compressed tablet is done and recorded
oil (Over- severity is rated as Hence occurrence is in BMR as per specified frequency in BMR and if any
lubrication of 5. rated as 1. discrepancy is observed in description of tablet then
punches and inform to production supervisor and QA and same is
dies) recorded in BMR.
Inadequate contamination Inadequate 5 Potential impact on 1 No such deviation  Samples are collected in sampling container / Poly bag
handling / Cross- status label on product quality reported from Nov- with duly labeled for In-process checking of In- process
of In- contamination in-process attributes. Hence 2020 to Till date. and Finished product.
process by product samples. severity is rated as Hence occurrence is  SOP for disposal of in- process samples is in- place.
samples. mix-up Inadequate 5. rated as 1.  Rejected material is reconciled after completion of
procedure for compression and rejected material is disposed as per
disposal of In- waste management SOP.
process
rejects
(waste).
Power Stoppage of Interruption in 4 Potential impact on 1 No such deviation  SOP for electrical power failure is available.
failure activity. electrical product quality reported from Nov-  Product is kept in closed condition if power is not
May have supply / attributes. Hence 2020 to Till date. resumed.
impact on Overload severity is rated as Hence occurrence is  SOP for Handling of deviation / incident in-placed.
environmental 4. rated as 1.
conditions
Compre Inadequate contamination Procedure not 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for tablet
ssion transfer of / Cross- available / product quality reported from Nov- compression machine” is in-place
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

identity. and QA Personnel.

 Coating material and batch to be coated (uncoated
tablets) is taken from respective, staging area as per
instruction mentioned in respective BMR.
Improper It may have Inadequate 5 Potential impact on 1 No such deviation  Coating solution is prepared as per instruction
coating impact on instruction for product quality reported from Nov- mentioned in respective BMR.
solution/ coating coating attributes. Hence 2020 to Till date.  Coating solution preparation process (Quantity of
suspension process solution severity is rated as Hence occurrence is materials, material addition flow, Purified water quantity
/ preparation 5. rated as 1. etc.) followed as per instruction mentioned in respective
dispersion BMR.
preparatio
n
Improper Mix-up of bad Incorrect 5 Potential impact on 1 No such deviation  Coating procedure is mentioned in approved BMR.
coating of tablets with parameters/ product quality reported from Nov-  Coating process parameters is set by production as per
compresse good product recipe set in attributes. Hence 2020 to Till date. instruction mentioned in BMR.
d tablets coater severity is rated as Hence occurrence is  During coating process, process parameter and In-
5. rated as 1. process check is performed and recorded in BMR.

Coating 5 Potential impact on 1 No such deviation  Coated tablets % weight gain is calculated as per
process product quality reported from Nov- instruction mentioned in BMR.
parameters attributes. Hence 2020 to Till date.  Description of the tablets is verified during in-process
and In- Hence occurrence is checks.
process check rated as 1.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

API residue to cleaning by Production and Quality Assurance.

next batch.  Equipment cleanliness is verified during line clearance
as per SOP.
 Trained personnel are involved in cleaning activity.
 Cleaning verification done for each batch of each
product.
4.25 Inspec- Improper contamination Inadequate 5 Potential impact on 1 No such deviation  Good tablets and rejected tablets are stored in different
tion handling / Cross- status label on product quality reported from Nov- containers with proper labeling.
stage of rejects contamination the product & attributes. Hence 2020 to Till date.
and by product rejects severity is Hence occurrence is
transfer of mix-up. container. rated as 1.
goods to
quarantine
area
Untrained 5 Potential impact on 1 No such deviation  Concerned staff is trained on respective SOPs.
person product quality reported from Nov-
attributes. Hence 2020 to Till date.
severity is rated as Hence occurrence is
5. rated as 1.

Product Defected Visual 5 Potential impact on 1 No such deviation  Visual inspector qualified and records are available.
defects is product may inspectors product quality reported from Nov-  Training of visual inspector done as per SOP.
not sorted packed in qualification attributes as well 2020 to Till date.  Procedure for medical checkup is available including the
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Visual 5 Potential impact on 1 No such deviation  Visual inspector qualified and records are available.
inspectors product quality reported from Nov-  Training of visual inspector done as per SOP.
qualification attributes as well 2020 to Till date.  Procedure for medical checkup is available including the
not done / as business loss. Hence occurrence is eye test.
available Hence severity is rated as 1.  Records of medical checkup retained with HR.
Procedure and rated as 5.
records for
Regular eye
check up
of visual
inspector not
available
4.27 Bottle Wrong Cross- Established 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for dry syrup
filling blend contamination Cleaning product quality reported from Nov- filling and sealing is in- place.
and material by retention, procedure not attributes. Hence 2020 to Till date.  SOP for Operation and cleaning procedure for induction
sealing selected leading to in-place severity is rated as Hence occurrence is sealing is in-place.
(operati for filling carryover of 5. rated as 1.  Visual inspection of the equipment is carried out after
on) API residue to cleaning by Production and Quality Assurance.
next batch.  Equipment cleanliness is verified during line clearance
as per SOP.
 Trained personnel are involved in cleaning activity.
 Cleaning verification done for each batch of each
product.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

new product at facility and after meeting acceptance

criteria, proceeded for commercial batches), hence
validated process parameters are recommended for
commercial batch Stage wise BMR is reviewed by
qualified person and BMR‟s are released for next stage
by QA.
Inadequate contamination Inadequate 5 Potential impact on 1 No such deviation  Samples are collected in sampling container / Poly bag
handling / Cross- status label on product quality reported from Nov- with duly labeled for In-process checking of In-process
of In- contamination in-process attributes. Hence 2020 to Till date. and Finished product.
process by product samples. severity is rated as Hence occurrence is  SOP for disposal of in- process samples is in- place.
samples. mix-up Inadequate 5. rated as 1.  Rejected material is reconciled after completion of dry
procedure for syrup filling process and rejected material is disposed as
disposal of In- per waste management SOP.
process
rejects
(waste).
Power Stoppage of Interruption in 4 Potential impact on 1 No such deviation  SOP for electrical power failure is available.
failure activity. electrical product quality reported from Nov-  Product is kept in closed condition if power is not
May have supply / attributes. Hence 2020 to Till date. resumed.
impact on Overload severity is rated as Hence occurrence is  SOP for Handling of deviation / incident in-placed.
environmental 4. rated as 1.
conditions
4.28 Bottle Improper Cross- Established 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for dry syrup
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

(Opera- may lead to  SOP provides instructions for storage and management
tion) cross- of change parts in designated storage cabinet.
contamination
by mix-up
Capsule Potential Inadequate 5 Potential impact on 1 No such deviation  Capsule filling process is carried out at controlled area
defects impact on area product quality reported from Nov- condition (temperature and RH) as per SOP.
like V- product temperature attributes. Hence 2020 to Till date.  Machine change part description mentioned in the BMR.
knocking, quality and and RH severity is rated as Hence occurrence is  The environmental conditions are verified before start of
Brittleness description, condition 5. rated as 1. the batch and after that defined frequency.
, capsule yield. Improper  In-process checking is performed as per SOP.
length etc. setting of  Analysis of Blended granules done as per approved
during capsule filling specification by quality control.
filling. machine
Problem in
granulation
process.
Foreign / Product Metal/Black 5 Potential impact on 1 No such deviation  Raw material is tested by QC and approved materials are
metal contamination particle in raw product quality reported from Nov- used for batch manufacturing.
particle May impact material or attributes. Hence 2020 to Till date.  In-process check (Description) of filled capsules is done
contami- product generated severity is rated as Hence occurrence is and recorded in BMR as per specified frequency in
nation description during 5. rated as 1. BMR.
processing.  Metal detectors are in- place to check and reject the
Metal detector metal contamination in product.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Power Stoppage of Interruption in 4 Potential impact on 1 No such deviation  SOP for electrical power failure is available.
failure activity. electrical product quality reported from Nov-  Product is kept in closed condition if power is not
May have supply / attributes. Hence 2020 to Till date. resumed.
impact on Overload severity is rated as Hence occurrence is  SOP for Handling of deviation / incident in-placed.
environmental 4. rated as 1.
conditions
4.30 Capsule Inadequate contamination Procedure not 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for capsule
filling transfer of / Cross- available / product quality reported from Nov- filling machine is in-place
machine uncleaned contamination Inadequate attributes. Hence 2020 to Till date.  Uncleaned parts are kept on SS/HDPE Pellets and SS
(Clean- parts to by mechanical procedure. severity is rated as Hence occurrence is trolley to Transfer to washing area labeled with status
ing) wash area transfer of Status label 5. rated as 1. label “To be cleaned”. Uncleaned parts are wrapped in
for loosely stuck on uncleaned polybag before transferring of uncleaned parts to
cleaning powder and parts not washing area for cleaning.
Inadequate capsules into affixed.  Personnel involved in the cleaning activity are trained on

Cleaning transit area procedure for labelling and qualified to carry out the
cleaning activity.
 Cleaning verification of each batch of each product
done.
5.0 Packing Area
5.1 labelling Wrong Potential Improper 5 Potential impact on 1 No such deviation  SOP for Operation and cleaning procedure for labelling
and packing impact on identification product quality reported from Nov- and packing is in- place.
packing material product and storage of attributes. Hence 2020 to Till date.  Visual inspection of the equipment is carried out after
selected quality and packing severity is rated as Hence occurrence is cleaning by Production and Quality Assurance.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

cleaning. 5. rated as 1. available.

Inadequate  Packing lines and verification of the same is done by
cleaning production and QA Line clearance is performed as per
verification SOP before start of each batch.
 Cleaning verification done for each batch of each
product.
Mix-up of Patient safety Wrong status 5 Potential impact on 1 No such deviation  Procedure for Status labeling is available and proper
products in Market labeling on product quality reported from Nov- status labeling is done at each stage.
in-process complaint. product in attributes. Hence 2020 to Till date.  The containers are labeled as per SOP. Two container
storage storage area. severity is rated as Hence occurrence is labels are affixed on each container. (One label outside
area 5. rated as 1. and other label inside the container).
 Container details (number. and weight) are recorded in
BMR which is further verified prior to starting the
packing activity.
Process Potential Mal- 5 Potential impact on 1 No such deviation  Preventive Maintenance Schedule is available and PM
failures: contamination functioning in product quality reported from Nov- done as per schedule.
Improper due to machine. attributes. Hence 2020 to Till date.  Breakdown Maintenance Procedure is Available to
Forming / reduced pack Wrong severity is rated as Hence occurrence is handle the breakdown.
Sealing of integrity. parameters 5. rated as 1.  Leak Test Apparatus and procedure for leak test is
Blister Product selected in available.
Pack Degradation machine.  CCP (i.e. Forming/sealing Temperature, Machine Speed)
due to Inadequate defined in the BPR.
improper leak test  Procedure for in-process checks for packing operation is
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

Equipment
not qualified
Mix-up of Patient safety Material 5 Potential impact on 1 No such deviation  Procedure for Status labeling is available and proper
product Market movement product quality reported from Nov- status labeling is done at each stage. Dispensed material
during complaint. without status attributes. Hence 2020 to Till date. labels are affixed on each packing material for
movement label. severity is rated as Hence occurrence is identification.
of 5. rated as 1.  No Market Complaint Received during this review
materials period.
in packing
area.
5.3 Primary Environ- contamination Power Failure 5 Potential impact on 1 No such deviation  Procedure electrical power failure is in place.
Packing mental across area by product quality reported from Nov-  Procedure for power backup in case of power failure is
(Core conditions airborne attributes. Hence 2020 to Till date. available and backup system starts immediately after
Area) not transfer. severity is rated as Hence occurrence is power cut to resume the activities.
maintained 5. rated as 1.  UPS provision is available for of critical equipment.
as per
Inadequate 4 Potential impact on 1 No such deviation  Differential Pressure, Temperature and %RH are
recording of product quality reported from Nov- recorded before start of packing operation and after
environ- attributes. Hence 2020 to Till date. every 02 hours as per SOP for monitoring of
mental severity is rated as Hence occurrence is environmental condition Instruction / procedure for
conditions. 4. rated as 1. covering of material if environmental conditions are not
within limit is mentioned in SOP.
 SOP for Handling of electrical power failure is in place.
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form
Identifi
cation Risk Analysis Risk Evaluation

Rationale for Severity

Occurrence Score (O)

Potential Impact or
Process Step / Unit
operation / System

Consequence of

Failure Event
Failure Event

Severity Score(S)
Potential Failure

Sr.
description

Rating
Rationale

Causes of
Event / Risk

Potential
Description

No.
for Current controls, Preventive Actions or Comments to
Occurrence Address Specific Cause
Rating

5.4 Seconda Transfer of Chances of Incorrect 5 Potential impact on 1 No such deviation  Each shipper label and verified by QA is placed on the
ry incorrect previous pack counting and product quality reported from Nov- shipper on a pallet.
Packing quantity of remnant in the reconciliation attributes. Hence 2020 to Till date.  Reconciliation of packed materials is done after
finished packing line of packed severity is rated as Hence occurrence is completion of packing operation as per BPR.
goods to having a goods. 5. rated as 1.  Finished goods Transfer note is prepared by production
warehouse potential and received by warehouse person.
cross-
contamination
risk with the
subsequent
product.
6.0 Finished Good Transfer
Distribut Improper Product Mix- Procedure not 5 Potential impact on 1 No such deviation  SOP for receipt and transfer Procedure of finished goods
ion of palletizatio up available / product quality reported from Nov- is in place to transfer the finished goods from packing to
Finished n of Damage of Inadequate attributes. Hence 2020 to Till date. warehouse.
Goods finished material procedure. severity is rated as Hence occurrence is  Warehouse person ensure that the Packing Department
(Dispatc goods. 5. rated as 1. stack the Finished Goods on pallets, product wise and
h) batch wise.
 In case the received finished goods are in damage or torn
condition, inform Packing department.
 After completion of all receiving activities warehouse
person store the material product wise or batch wise.
 During clearance of finished goods from the factory,
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

10. CONCLUSION
Risk assessment for the Manufacturing process of Oral Solid Dosage has been done as per FMEA-Quantitative Risk Management approach to evaluate the each u
process step/stage and current control procedures available at site. Standard operating procedures are available and effective. Hence facility has effective current
during the risk assessment.

11. RISK COMMUNICATION

11.1 CAPA / CHANGE CONTROL / DEVIATION REFERENCE:

Sr. No. CAPA / Change Control / Deviation Reference No. Date of CAPA / Change Control / Deviation
 Department: Quality Assurance QRM No.:
SUBJECT : Risk Assessment for Manufacturing process of Oral Solid Dosage form

12. QUALITATIVE SCALE FOR SEVERITY, OCCURRENCE AND DETECTION

RISK ASSESSMENT SCORING MATRIX
Certain 10 20 30 40 50 60 70 80 90 100
Almost Certain 9 18 27 36 45 54 63 72 81 90
Very Likely 8 16 24 32 40 48 56 64 72 80
Probable 7 14 21 28 35 42 49 56 63 70
Likely 6 12 18 24 30 36 42 48 54 60
Likely 5 10 15 20 25 30 35 40 45 50
May Happen 4 8 12 16 20 24 28 32 36 40
Improbable 3 6 9 12 15 18 21 24 27 30
Unlikely 2 4 6 8 10 12 14 16 18 20
Very Unlikely 1 2 3 4 5 6 7 8 9 10
Insignificant Injury

Multiple Fatalities
Single Fatality
Major Injury

Major Injury
Minor Injury

Minor Injury

Illness Injury

Illness Injury

Fatality
Key
No Significant 0 to 3 May be Ignored, No Further Action Required
Very Low 4 to 12
Ensure Safe Working
Low 13 to 25
Moderate 26 to 42 Refer to Risk Assessment, Safe Working Procedures
High 43 to 67 Monitor Controls Measures
Very High 68 to 100 Avoid If Possible, Full Method Statement if Not

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