PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
Dispensing *D
1. Dispensing  Unapproved  Unapproved  Lack of Qualified  Qualification procedure 4 1 1 4 NA N N NA NA
stage-Before source of API and is in place and also line A A

Vendor Management
material gets dispense material
start of dispense leads to product excipient clearance check point is
Dispensing  Failed contamination.  Lack of testing available in BMR to
specification. ensure approved &
material get  Fails to achieve
 Lack of vendor release materials are
dispense the safety, management available for
efficacy and procedure dispensing.
quality of  Testing specifications
product. are in place.
 Vendor management
procedure is in place.

FORMAT No.: Page No.: 1 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
At time of  Fails to  Inadequate result  Due to selection of  Selection of weighing 3 2 1 6 NA N N NA NA
*D

Balances, Dispensing and issuance of sterile RM and Dispensing

Dispensing dispense the due to improper wrong capacity balance is depending on A A

Operation, Cleaning, Calibration and Verification of Weighing

required quantity weighing balance. balance capacity and
quantity. dispensing and  Due to lack of quantity of material.
 SOP is in place for
 Dispense improper testing operational and operation and
material get outcomes (OOS). calibration calibration procedure of
contaminate.  Contamination of procedure of weighing balances.
the area leads to weighing balance.  Environmental
product failure  Due to improper condition check point is
environmental in place in line
conditions. clearance checklist.
 Due to lack of the  Uses and cleaning of
operation and dispensing tool SOP is
in place.
cleaning procedure  Dispensing of API,
for dispensing tools. excipient and PM SOPs
 Due to lack of are in place.
procedure for  Training has been
dispensing imparted to concerned
 Material dispensed personnel’s.
by untrained  In dispensing activity
personnel. done by and checked by
 No cross check provision is available in
BMR and verification
during dispensing done by before
 Unapproved/rejecte compounding.
d material  Check point is in place

of PM
dispensed. in BMR to check
material is
approved/released.

FORMAT No.: Page No.: 2 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
2. Component  Failure of  Improper cleaning  Due to lack of  Qualification of 3 2 1 6 NA. N NA NA NA
*D
preparation Component and sterilization unqualified sterilizer. sterilizer has been A

Operation and Cleaning of Autoclave Cum Bung Processer

preparation of component  Lack of component completed.
and leads to cleaning and  Component cleaning
component and sterilization SOP is
sterlization. contamination in sterilization in place.
product. procedure.  If the steam lack occurs
 Steam lack or utility during sterilization
cut off during phase, alarm will
sterilization phase. generate and same shall
 Articles cleaning and be acknowledged by
sterilization by operator and cycle will
untrained person. be considered as abort.
 Load pattern may not  Training has been
follow. imparted to all
 Selection of wrong concerned persons.
recipe.  Validated load patterns
 Sensor should be refers before
malfunctioning. start of activity as per
 Due to sterilization, respective SOP.
material hold time  Validated recipe and
cross parameter has been set
in autoclave PLC and
controlled through
password.
 Defined frequency in
place for schedule
calibration, Preventive
maintenance and
validation status.
 Sterilized hold time has
been established and
actual material hold
time is track in BMR.

FORMAT No.: Page No.: 3 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
3. During Filter  Failure in  Improper filter  Unqualified  Qualification of filter 5 1 1 5 NA N N NA NA
*D
Integrity filter integrity integrity gets equipment used. integrity machine has A A
testing direct impact on  Lack of cleaning been completed.
sterility of and operational  Cleaning and
product. SOP. Operational SOP is in
 Filter integrity place

Operation of Integrity Tester

activity performed  Training has been
by untrained imparted to all
person. concerned persons
 No cross checks and user ID given
provision for filter after completion of
integrity test report. training.
 Filter integrity test
report (Pre and Post)
shall be checked by
production person
and verified by QA
person.

FORMAT No.: Page No.: 4 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
4. During  Failure in  Due to improper  Compounding  Detail, compounding 5 3 1 15 Sample shall 5 1 1 5*D
compounding Batch manufacturing procedure not procedure is in place be collected
manufacturing procedure leads to available. in BMR. for QC
bioburden may  Due to lack of  Vessel calibration, analytical and
increase more calibration preventive QC

CIP of Mixing vessel, Mixing mobile vessel, holding vessel

than specification. ,preventive maintenance, microbiologica
 Unexpected maintenance, operational and l to check the

Load Cell Verification and Calibration of Manufacturing Vessels

outcome like operational and cleaning procedure impact of CPP
yield and cleaning are in place. on CQA.
concentration of procedures.  Qualification of CPP and CQA
product leads to  Qualification of vessels system is shall be
product failure. vessel system not completed. evaluated after
available.  In line clearance of completion of
 Unsterlized and compounding activity process
unclean equipment ensure the validation
may use. sterilization vessels activity.
 Inadequate cleaning shall be mention in
or equipment’s BMR.
difficult to clean.  Vessels CIP, SIP
 Compounding procedure are
activity handle by qualified and SOP is
untrained person. in place.
 Due to lack of clean  Training has been
equipment hold completed for all
time may cross. concerned persons.
 Micro growth due  CIP hold time has
to utility supply been established.
such as WFI,  Water system
Compressed air and compressed air and
nitrogen. Nitrogen are
qualified.

FORMAT No.: Page No.: 5 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
5. Filtration  Failure in  Filtrate is not  Lack of procedure  SOP is in place for 5 3 1 15 Sample shall 5 1 1 5*D
activity filtration of sterile leads to for sterilization of SIP of vessel system be collected
bulk solution microbial growth. filter. along with product for QC
 Improper  Lack of procedure transfer line. analytical and
filtration leads to to check the filter  Filter integrity QC
contamination in integrity. procedure is in place microbiologica
product.  Due to improper check points is l to check the

SIP for Mixing Vessel/ MMV/ Holding

training to available. effect of
concerned persons.  Training procedures filtration.
 Lack of filtration is in place.
procedures.  Filtration procedure
is available in BMR.

Vessel/Buffer Vessel

FORMAT No.: Page No.: 6 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
6. Bulk Hold  Failure in  During bulk  Lack of  Qualification of the 5 3 2 30 Product hold 5 1 1 5*D
Bulk Hold solution hold qualification of vessel system has time shall be
period bioburden vessel system. been completed. establish during
may increase  Lack of aseptic  Aseptic connection process
validation
more than the connection. for filtration is batches.
specification.  Lack of positive defined in BMR.
pressure.  The vessel is closed
 Due to failure of system and operated
filter integrity of through control HMI.
vent filters. The vessel kept under
 Lack of provision to positive pressure
monitor the during bulk hold
pressure in vessel. which does not allow
 Due to activity the infiltration of
handle by untrained microbial
person. contaminants.
 Lack of established  The procedure is in
bulk hold time. place for pre and post

Handling of Filters
filter integrity for
vent filter.
 Magnehelic guage is
there for monitoring
the pressure
 Training procedure is
in place for operation
of the vessel.

FORMAT No.: Page No.: 7 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
7. Vial washing  Failure in  Improper vial  Lack of qualified  Qualification has 5 1 1 5 NA N N NA NA
*D
vial washing washing equipment. been completed for A A
procedure leads  Lack of operational vial washing
to contamination procedure. machine.

Operation and Cleaning of Vial

 Due improper  Due to activity  Operational SOP is in
cleaning handled by place.
particulate matter untrained person.  Training has been
may presence in  Due to lack of imparted to
vials and leads to cleaning operation concerned persons.

Washing Machine
failure in visual and preventive  Cleaning, operational
inspection. maintenance and preventive
procedure. maintenance
 Due to improper procedures is in
utility supply. place.
 SOP is in place for
parameter of utility
supply.

FORMAT No.: Page No.: 8 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
8. Tunnel  Failure in  Improper  Unqualified  Qualification has 5 2 2 20 5 1 1 5
*D
operation vials  depyrogenation equipment may use. been completed for

Operation of Cleaning of Sterilizing & Depyrogenation Tunnel


depyrogenatio leads BET and  Lack of cleaning tunnel.
n.  sterlity Failure. and operational  Operational SOP is in
 Failure in tunnel procedure. place.
leads to loss of  Untrained person  Training has been
time and may operate imparted to
resources. machine concerned persons.
 Tunnel temperature  Cleaning SOP is in
and DP fluctuation place.
during batch  Tunnel conveyer belt
activity will stop
 Selection of wrong automatically if
parameters and sensor temperature
recipe goes out of set point.
 Sensor The intervention has
malfunctioning. been performed in
media fill batch.
 Defined frequency is
in place for schedule
calibration,
temperature sensor,
Preventive
maintenance and
validation status of
tunnel sterilizer.
 Validated recipe and
parameter is in place.

FORMAT No.: Page No.: 9 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
9. Filling  Failure in  Improper filling  Lack of  Qualification of 5 2 2 20 If in case any 5 1 1 5
*D
operation filling and may result in qualification filling and stoppering unexpected

Operation and Cleaning of Automatic High Speed Injectable

stoppering volume variation. procedure. machine has been intervention
 Improper filling  Lack of cleaning completed. will happen
and stoppering and operational  SOP for filling during batch
activity may procedure. machine cleaning and processing
leads to  Unsterile parts or operation is in place. same shall be
contamination. article may use I  Sterilization documented
filling operation. procedure for and handled
 Lack of machine parts loads through QMS.
environmental is in place.

Powder Filling and Stoppering Machine

condition for filling.  Filling shall be
 Improper handling carried out under
of aseptic class A
intervention may condition(Unidirectio
lead to product nal air flow area)
contamination.  Aseptic intervention
 Operation handled shall be performed as
by untrained and per media fill
unqualified person. protocol and BMR.
 Due aseptic  Operational training
interventions has been done for all
 Due filling concerned persons
duration. for aseptic.
 Filling duration is
mentioned in BMR
and same was
simulated in media
fill.

FORMAT No.: Page No.: 10 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
10. Capping  Failure in vial  Improper  Unqualified  Qualification for 5 1 1 5 NA N NA NA NA
*D

Dropper Fixing & Screw Capping

operation sealing crimping is not equipment may capping machine has A

Operation & Cleaning of Filling,

providing leak use. been completed.
proof sealing to  Operational and  Operational and
the vials. cleaning cleaning SOP is in
 Failure in capping procedure may place.
activity leads to not available.  Training has
product  Untrained person imparted to
contamination. may operate concerned persons.
machine.  SOP is in place for
 Lack of leak test leak test for sealed
procedure for vial and container

Machine
sealed container. closer integrity test
has been established
in media fill batch.

FORMAT No.: Page No.: 11 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
11. Visual  Failure in  Improper visual  Lack of  Visual inspector 3 1 5 15 NA 1 1 5 5*D
Inspection visual inspection of qualification qualification

Operation Cleaning of Automatic Visual

inspection vials leads to procedure for procedure is in place.
direct impact on visual inspector.  SOP is inplace for
product quality  Lack of SOP for Automatic optical
and patient visual inspection inspection activity.
safety. procedure.  Qualification has
 Improper visual  Visual inspection been completed for
inspection to activity done by concerned persons.
vials gets market unqualified  Inprocess checks is in
complaints to the person. place for visual

Inspection Machine
organization.  Lack of cross inspection activity
check procedure and AQL is in place.
for inspected vial.
 Visual inspection
hood not
qualified.
 Lack of required
lux level.
12. Storage  Improper  Chance of  Lack of SOP  SOP for handling of 1 1 5 5 NA N NA NA NA
condition in storage space product mix-up  Lack of dedicated finished good is in A

Handling Of Finished
FG and conditions due to lack of storage space place.
in Finished dedicated space.  Due to  Dedicated storage
goods store.  Chance of environmental space is available.
product condition not  Environmental
degradation due maintain. condition is
to irrespective monitoring through

Goods
storage BMS.
condition.

FORMAT No.: Page No.: 12 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Risk Recommend- Post Risk
Item/ Potential Potential Effect of
S. Potential Cause/ Priority ended RP
Function Failure Mode Failure Current Control Reference S O D
No. Mechanism of Failure Number Actions S O D N
(Failure Mode ) (Effect)
(S*O*D) (if any) S*O
13. Labelling  Improper  Improper  Lack of SOP of  SOP of labeling 1 1 5 5 NA N NA NA NA
*D
A

Issuance of Packing
Activity Labelling in labeling leads to Labeling machine machine is in place.
Product. adverse effect on  Lack of Line  Training imparted to

Dispensing and
patient health. clearance and IPQA person for Line
physical clearance and proof
verification. check.

Material
 Lack of proper  SOP of Packing
Dispensing of material Dispensing
Packing material. is in place.

14. Secondary  Improper  Improper  Lack of SOP of  SOP of operation and 1 1 5 5 NA N NA NA NA

Packing packing of the packing leads to carton packing cleaning of Hi-cart A

Operation and Cleaning

activity product. product damage.  Lack of Line carton packing

of Hi-cart Cartoning
 Wrong packing clearance and machine is in place.
leads to risk on physical  Training imparted to
patient safety. verification. IPQA person for Line
 Lack of proper clearance and proof
Dispensing of check.

Machine
Packing material.  SOP of Packing
material Dispensing
is in place.

FORMAT No.: Page No.: 13 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION
Where: S=Severity; O=Occurrence Probability; D=Detection; Risk category 1-25 RPN is Low risk, 26-50 RPN is Medium Risk, 51-125 RPN is High Risk.

Name of Facility/Equipment/Utility/System/Activity/Procedure/Unit Operation: Purified water generation Date:

& distribution system

Target Date
S.No. Recommended Action Responsible Person
of Completion

1.

2.

CAPA:
If required, mention CAPA No.:
Reviewed By Approved By
Quality Risk Management Team
Head Operations Head QA
Sign & Date Sign & Date
Name Department Sign & Date

FORMAT No.: Page No.: 14 of 25

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

QRA No.:
Name of Facility/Equipment/Utility/System/Activity/Procedure
Date Of Quality Risk Assessment:
Unit Operation: PROCESS VALIDATION

QUALITY RISK ASSESSEMENT AND MITIGATION SUMMARY REPORT

Name of Equipment:

Verification of Action Plan: NA

Remarks (if any): The entire above failure mode and their Severity, Occurrence, Detection rating done and RPN No. is found between 1-25. Hence Risk is
detected as low which is acceptable.

Verified By Approved By
QA Head QA
Sign & Date Sign & Date

FORMAT No.: Page No.: 15 of 25