PERFORMANCE QUALIFICATION
REPORT
FOR
HORIZONTAL/ VERTICAL/ REVERSE
LAMINAR AIR FLOW
EQUIPMENT ID No.
LOCATION Injection Block
DATE OF QUALIFICATION
SUPERSEDED PROTOCOL No.
REPORT CONTENTS
S. No. SUBJECT PAGE No.
1.0 REPORT PRE APPROVAL 3
2.0 OBJECTIVE 4
3.0 SCOPE 4
4.0 RESPONSIBILITY 4
5.0 EQUIPMENT DETAILS 5
6.0 PRE-REQUALIFICATION REQUIREMENTS 5
7.0 TESTS & CHECKS 7
8.0 CHECK LIST OF ALL TESTS & CHECKS 19
9.0 DOCUMENTS ATTACHED 19
10.0 NON-COMPLIANCE 19
11.0 DEVIATION FROM PRE DEFINED SPECIFICATION 19
12.0 CHANGE CONTROL 19
13.0 REVIEW 19
14.0 CONCLUSION 20
15.0 RECOMMENDATION 20
16.0 ABBREVIATION 20
17.0 REPORT POST APPROVAL 21
1.0 PROTOCOL APPROVAL:
INITIATED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(PRODUCTION)
HEAD
(ENGINEERING)
HEAD
(QUALITY CONTROL)
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
MANAGER
(QUALITY ASSURANCE)
APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)
2.0 OBJECTIVE:
To compile the Validation report carried out as per Protocol No. for Horizontal/ Vertical/ Reverse
Laminar Air Flow of Production Area, Injection Block and Warehouse used for supplying Laminar Air
Flow and maintain the air cleanliness as per ISO class 5 level.
3.0 SCOPE:
The Report covers all aspects of Performance Qualification for Horizontal/ Vertical/ Reverse Laminar
Air Flow installed in Production Area, Injection Block and Warehouse used for supplying Laminar Air
Flow and maintain the air cleanliness as per ISO class 5 level.
4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following Departments, shall be
responsible for the overall compliance of this Report:
DEPARTMENTS RESPONSIBILITIES
Shall prepare & Review the performance requalification protocol as per
the Regulatory guideline and Validation Master Plan.
Execution of the performance requalification protocol with Production,
Quality Control & Maintenance department: verification of components
calibration records of instrument. Verification of test & Results.
Deficiency (if any) & Corrective Action. Shall compile the data &
Quality Assurance
Prepare summary report
Performance requalification protocol shall be approved by the QA prior
and after the execution.
Shall review the executed protocol to check the compliance and
corrective action for any discrepancies found. Also shall prepare the
summary and conclusion of the performance requalification study.
Review of Performance Qualification Protocol.
Production
To co-ordinate and support Performance Qualification Activity.
Review of Performance Qualification Protocol.
Engineering To co-ordinate and support Validation Activity.
Responsible for Trouble shooting during execution (If occurs).
5.0 EQUIPMENT DETAILS:
Equipment Name Horizontal/ Vertical/ Reverse Laminar Air Flow
Equipment ID.
Manufacturer’s Name
Supplier’s Name
Place of Installation
6.0 PRE-QUALIFICATION REQUIREMENTS :
1.1 SYSTEM PRE-REQUISITES:
VERIFIED BY
DOCUMENT/ COMPLETED (SIGN &
S. No. DOCUMENT NAME
SOP No. (YES/NO) DATE)
QA
1.2 TEST EQUIPMENT CALIBRATION:
S. No EQUIPMENT/ EQUIPMENT/ CALIBRATION CALIBRATION VERIFIED BY
INSTRUMENTS INSTRUMENTS DONE ON DUE ON (SIGN &
NAME ID DATE)
QA
1.3 TRAINING OF EXECUTION TEAM
S. No. Name of Trainee Department Designation Acceptance Signature Checked
Criteria of Trainee By
(Sign &
Date)
QA
1.
2.
3.
4.
All personnel
5.
involved in
6.
execution of
7.
protocol should be
8.
trained in the
9.
required
10.
procedure and
11. documented.
12.
13.
14.
15.
Name of the Trainer: _______________
Sign & Date: _______________
Inference:_____________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
7.0 TESTS AND CHECKS:
1.4 RESULTS OF AIR VELOCITY:
DATE OF TEST:
HEPA Filter Acceptance
Equip. ID. Room Name Avg. Velocity
No. Criteria
01
Garment Transfer
02
01
Garment Transfer
02
01
Equipment Washing
02
01
Vial Filling Room
02
01
Vial Filling Room
02
01
Vial Filling Room 02
03
Vial Filling Room 01
01
Vial Sealing Room
02
01
Cool Zone 02
03 90±1`20%
01 ft. /min
02
Cool Zone
03
04
01
Blending 02
03
Garment Autoclave 01
Unloading Area 02
01
Solution Preparation 02
03
Mobile LAF 01
Dynamic Garment Cubical 01
01
RM Sampling & Dispensing 02
03
01
RM Store (Ware House)
02
Compiled By:
(Quality Assurance)
(Sign/Date)
Inference:______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
1.5 RESULT OF FILTER INTEGRITY TEST (PAO TEST):
DATE OF TEST:
HEPA FILTER INTEGRITY TEST
HEPA Upstream Downstream Result
Room Name Filter concentration concentration Limit (Pass/
Equipment ID.
No. (% ) (% Leakage) Fail)
Garment 01
100%
Transfer 02 NMT 0.01%
Garment 01
100%
Transfer 02 NMT 0.01%
Equipment 01
100% NMT 0.01%
Washing 02
Vial Filling 01
100% NMT 0.01%
Room 02
Vial Filling 01
100% NMT 0.01%
Room 02
01
Vial Filling
02 100% NMT 0.01%
Room
03
Vial Filling
01 100% NMT 0.01%
Room
Vial Sealing 01
100% NMT 0.01%
Room 02
01
Cool Zone 02 100% NMT 0.01%
03
01
02
Cool Zone 100% NMT 0.01%
03
04
01
Blending 02 100% NMT 0.01%
03
Autoclave 01 NMT 0.01%
Unloading 100%
Area 02
01
Solution
02 100% NMT 0.01%
Preparation
03
DATE OF TEST:
HEPA FILTER INTEGRITY TEST
HEPA Upstream Downstream Result
Room Name Filter concentration concentration Limit (Pass/
Equipment ID.
No. (% ) (% Leakage) Fail)
Mobile LAF 01 100% NMT 0.01%
Dynamic
Garment 01 100% NMT 0.01%
Cubical
01
RM
Sampling & 02 100% NMT 0.01%
Dispensing
03
01
RM Store 100% NMT 0.01%
02
Compiled By:
(Quality Assurance)
(Sign/Date)
Inference:______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
1.6 RESULTS OF DIFFERENTIAL PRESSURE MONITORING:
DIFFERENTIAL PRESSURE
Room Differential Pressure (mm of WC)
Equipment ID.
Name Acceptance
Day-1 Day-2 Day-3 Date Of Test
Criteria
Garment 10-30
Transfer mmWC
Garment 10-30
Transfer mmWC
Equipment 100-300
Washing pascal
Vial Filling 100-300
Room pascal
Vial Filling 100-300
Room pascal
Vial Filling 100-300
Room pascal
Vial Filling 10-30
Room mmWC
Vial
Sealing 100-300
pascal
Room
Cool Zone 10-30
mmWC
Cool Zone 10-30
mmWC
Blending 10-30
mmWC
Autoclave
Unloading 10-30
mmWC
Area
Solution 10-30
Preparation mmWC
Mobile 10-30
LAF mmWC
Dynamic
Garment 10-30
mmWC
Cubical
RM
Sampling 10-30
& mmWC
Dispensing
RM Store 10-30
mmWC
Compiled By:
(Quality Assurance)
(Sign/Date)
Inference:______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
1.7 RESULTS OF NON-VIABLE PARTICLE COUNT TEST
NON-VIABLE PARTICLE COUNT TEST
Acceptance
Criteria (both in
Observed Value
Equipment At rest & in
Room Name Location ISO operation Date Of
ID.
No. Class Particle per cubic Test
No. No.
meter
Particles Particles
≥ 5.0
≥ 0.5 µm ≥ 5.0 µm ≥ 0.5 µm
µm
01
Garment
02 5 3520 00
Transfer
03
01
Garment
02 5 3520 00
Transfer
03
01
Equipment
02 5 3520 00
Washing
03
01
Vial Filling
02 5 3520 00
Room
03
01
Vial Filling
02 5 3520 00
Room
03
01
Vial Filling
02 5 3520 00
Room
03
01
Vial Filling
02 5 3520 00
Room
03
01
Vial Sealing
02 5 3520 00
Room
03
01
Cool Zone 02 5 3520 00
03
01
Cool Zone 02 5 3520 00
03
01
Blending 02 5 3520 00
03
Autoclave 01
Unloading 02 5 3520 00
Area 03
01
Solution
02 5 3520 00
Preparation
03
NON-VIABLE PARTICLE COUNT TEST
Acceptance
Criteria (both in
Observed Value
Equipment At rest & in
Room Name Location ISO operation Date Of
ID.
No. Class Particle per cubic Test
No. No.
meter
Particles Particles
≥ 5.0
≥ 0.5 µm ≥ 5.0 µm ≥ 0.5 µm
µm
01
Mobile LAF 02 5 3520 00
03
Dynamic 01
Garment 02 5 3520 00
Cubical 03
RM 01
Sampling & 02 5 3520 00
Dispensing 03
01
RM Store 5 3520 00
02
03
Compiled By:
(Quality Assurance)
(Sign/Date)
`
Inference:
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
1.8 MICROBIOLOGICAL MONITORING:
1.8.1 By Settle plate
BIOBURDEN MONITORING
CFU/plate/4 hrs.
Equipment Room
ID. Name
Day-1 Day-2 Day-3
Date of
Bacterial Fungal Bacterial Fungal Bacterial Fungal Test
Count count Count count Count count
Garment
Transfer
Garment
Transfer
BIOBURDEN MONITORING
CFU/plate/4 hrs.
Equipment Room
ID. Name
Day-1 Day-2 Day-3
Date of
Bacterial Fungal Bacterial Fungal Bacterial Fungal Test
Count count Count count Count count
Equipment
Washing
Vial Filling
Room
Vial Filling
Room
Vial Filling
Room
Vial Filling
Room
Vial
Sealing
Room
Cool Zone
Cool Zone
Blending
Autoclave
Unloading
Area
Solution
Preparation
Mobile
LAF
Dynamic
Garment
Cubical
RM
Sampling
&
Dispensing
RM Store
ACCEPTANCE CRITERIA:
GRADE A
Acceptance Limit CFU/plate/4Hrs
<1
Compiled By:
(Quality Assurance)
(Sign/Date)
Inference:______________________________________________________________________________
_______________________________________________________________________________________
_____________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
1.8.2 By Active Air Sampling
BIOBURDEN MONITORING
CFU/M3
Equipment Room
ID. Name
Day-1 Day-2 Day-3
Date of
Bacterial Fungal Bacterial Fungal Bacterial Fungal Test
Count count Count count Count count
Garment
Transfer
Garment
Transfer
Equipment
Washing
Vial Filling
Room
Vial Filling
Room
Vial Filling
Room
Vial Filling
Room
Vial
Sealing
Room
Cool Zone
Cool Zone
BIOBURDEN MONITORING
CFU/M3
Equipment Room
ID. Name
Day-1 Day-2 Day-3
Date of
Bacterial Fungal Bacterial Fungal Bacterial Fungal Test
Count count Count count Count count
Blending
Autoclave
Unloading
Area
Solution
Preparation
Mobile
LAF
Dynamic
Garment
Cubical
RM
Sampling
&
Dispensing
RM Store
GRADE A
Acceptance Limit
< 1CFU/M3
ACCEPTANCE CRITERIA:
Compiled By:
(Quality Assurance)
(Sign/Date)
Inference:______________________________________________________________________________
_______________________________________________________________________________________
_____________________________________________________________________________
Reviewed By:___________________
(Manager QA)
(Sign & Date)
8.0 CHECKLIST OF ALL TESTS AND CHECKS:
S. No. TESTS OR CHECKS
01 Air Velocity
02 Filter Integrity Test (PAO Test)
03 Differential Pressure Monitoring
04 Air Flow Pattern Test (Smoke Test)
05 Non-Viable Particle Count Test
06 Microbiological Monitoring
9.0 DOCUMENTS ATTACHED:
External Agency Instruments Traceability
Certificates from External Agency.
Microbiological Test Report.
10.0 NON COMPLIANCE:
11.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:
12.0 CHANGE CONTROL, IF ANY:
13.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) :
14.0 CONCLUSION:
15.0 RECOMMENDATION:
16.0 ABBREVIATIONS:
Ml : Milliliter
No. : Number
Ltd. : Limited
ID No. : Identification Number
QA : Quality Assurance
SOP : Standard Operating Procedure
17.0 REPORT POST APPROVAL:
INITIATED BY:
DESIGNATION NAME SIGNATURE DATE
OFFICER/EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(PRODUCTION)
HEAD
(ENGINEERING)
HEAD
(QUALITY CONTROL)
REVIEWED BY:
DESIGNATION NAME SIGNATURE DATE
MANAGER
`
(QUALITY ASSURANCE)
APPROVED BY:
DESIGNATION NAME SIGNATURE DATE
HEAD
(QUALITY ASSURANCE)
