PQ of 107 Liquid Manufacturing Tank

Pacific Pharmaceuticals Ltd.
CONFIDENTIAL
Performance Qualification Protocol for Liquid Manufacturing Revision 02
Tank (PRTK-107)
PERFORMANCE QUALIFICATION PROTOCOL
LIQUID MANUFACTURING TANK (PRTK – 107)
Protocol Number: TK-PQ-18-060
Protocol Date: January 10, 2018
Prepared by: Validations Department
Pacific Pharmaceuticals Ltd
Lahore-Pakistan
___________________________________________________________________________________
Date: Jan. 10, 2018 Page 1 of 8 protocol # TK-PQ-18-060
Pacific Pharmaceuticals Ltd. CONFIDENTIAL
Tank (PRTK-107)
AUTHOR:
Name: Ammar Ali Title: Validation Officer
Signature: ___________________ Date: ______________
APPROVAL
VALIDATION :
Name: M. Farhan Bhatti Title: Deputy Manager Validation
Signature: ___________________ Date: ______________
ENGINEERING:
Name: Naveed Iqbal Title: Plant Engineer
Signature: ___________________ Date: ______________
QUALITY ASSURANCE:
Name: Ghazi Mustansar Riaz Title: General Manager Quality Assurance
Signature: ___________________ Date: ______________
AUTHORIZED BY
DIRECTOR OPERATIONS:
Name: Afifa Irfan Title: Director Operations
Signature: ___________________ Date: ______________
___________________________________________________________________________________
Tank (PRTK-107)
TABLE OF CONTENTS
No. TITLE PAGE #
1. OBJECTIVE-----------------------------------------------------------------------------------------4
2. SCOPE------------------------------------------------------------------------------------------------4
3. RESPONSIBILITY---------------------------------------------------------------------------------4
4. OPERATIONAL AND PERFORMANCE QUALIFICATION TESTS--------------------5
5. VARIATION/ DEVIATION/MAJOR MAINTENANCE SINCE LAST PQ--------------6
6. PROCEDURES--------------------------------------------------------------------------------------7
7. STATISTICAL ANALYSIS-----------------------------------------------------------------------8
___________________________________________________________________________________
Tank (PRTK-107)
1.0 OBJECTIVE:
The objective of this protocol is to describe performance qualification (PQ) experiments

for Liquid Manufacturing Tank.
2.0 SCOPE
This scope of this PQ pertains to qualification of Liquid Manufacturing Tank, ID # PRTK

– 107
3.0 RESPONSIBILITY:
3.1 It is the responsibility of Liquid Section operator to perform PQ test as

described in this protocol according to the standard operating procedures #
PRSY/02/0017
3.2 It is the responsibility of Validation officer to collect raw data
3.3 It is the responsibility of validations department to prepare performance

qualifications protocol
3.4 It is the responsibility of validation, engineering and quality assurance managers

to approve the protocol
3.5 It is the responsibility of director operations to authorize the protocol
Instrument / Equipment / System : Liquid Manufacturing Tank

Location : Liquid
Department :Production ID # : PRTK-107
Section
To be performed after ,
Re-Operational Qualification Modification Relocation Out of Spec. Results or √ Re-Qualification

Reason for above selection: To qualify performance parameters of Liquid Manufacturing Tank after 5
years.
4.0 Operational and Performance Qualification Tests:
No Test to be performed Acceptance Criteria
___________________________________________________________________________________
Tank (PRTK-107)
1 Speed Up to 500 RPM

(max)
2 Volume Up to 1000 Liter

(capacity)
3 Temperature 22°C -26°C (Room Temperature)
5.0 Variation/ Deviation/ Major maintenance Since Last PQ:
Description Of Deviation/ Performance Impact

Sr. No. Status last PQ
Change/Major Maintenance Assessment
1 Deviation/ Change/ Major
___________________________________________________________________________________
Tank (PRTK-107)
2 Results Variation
3 Major Maintenance
6.0 Procedures:
To evaluate performance qualification of Liquid Manufacturing Tank (PRTK-107), the following
products were selected to perform the run.
Sr. Test 1
Test Parameters Acceptance Criteria
No. Product Information
Product Product 1
1 Speed (RPM) As per BMR
Name
2 Batch No Volume (Liter) As per BMR
Batch
3 Temperature (°C) As per BMR
Size
Date of
4
PQ
5 Stage
___________________________________________________________________________________
Tank (PRTK-107)
Sr. Test 2
Product Product 2
Name
Batch
Size
Date of
4
PQ
5 Stage
Sr. Test 3
Product Product 3
Name
Batch
Size
Date of
4
PQ
5 Stage
7.0 Statistical Analysis

(Perform any calculation regarding test, if required on this page)
No. Statistical Analysis
___________________________________________________________________________________
Tank (PRTK-107)
1 Mean
2 Standard deviation
3 Coefficient of Variance
___________________________________________________________________________________

PQ of 107 Liquid Manufacturing Tank

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Pacific Pharmaceuticals Ltd.

PERFORMANCE QUALIFICATION PROTOCOL

LIQUID MANUFACTURING TANK (PRTK – 107)

Protocol Number: TK-PQ-18-060

Protocol Date: January 10, 2018

Prepared by: Validations Department

Pacific Pharmaceuticals Ltd

Name: Ammar Ali Title: Validation Officer

Signature: ___________________ Date: ______________

Name: M. Farhan Bhatti Title: Deputy Manager Validation

Signature: ___________________ Date: ______________

Name: Naveed Iqbal Title: Plant Engineer

Signature: ___________________ Date: ______________

Name: Ghazi Mustansar Riaz Title: General Manager Quality Assurance

Signature: ___________________ Date: ______________

Name: Afifa Irfan Title: Director Operations

Signature: ___________________ Date: ______________

No. TITLE PAGE #

4. OPERATIONAL AND PERFORMANCE QUALIFICATION TESTS--------------------5

5. VARIATION/ DEVIATION/MAJOR MAINTENANCE SINCE LAST PQ--------------6

The objective of this protocol is to describe performance qualification (PQ) experiments

This scope of this PQ pertains to qualification of Liquid Manufacturing Tank, ID # PRTK

3.1 It is the responsibility of Liquid Section operator to perform PQ test as

3.2 It is the responsibility of Validation officer to collect raw data

3.3 It is the responsibility of validations department to prepare performance

3.4 It is the responsibility of validation, engineering and quality assurance managers

3.5 It is the responsibility of director operations to authorize the protocol

Instrument / Equipment / System : Liquid Manufacturing Tank

Re-Operational Qualification Modification Relocation Out of Spec. Results or √ Re-Qualification

4.0 Operational and Performance Qualification Tests:

No Test to be performed Acceptance Criteria

1 Speed Up to 500 RPM

2 Volume Up to 1000 Liter

3 Temperature 22°C -26°C (Room Temperature)

5.0 Variation/ Deviation/ Major maintenance Since Last PQ:

Description Of Deviation/ Performance Impact

1 Deviation/ Change/ Major

7.0 Statistical Analysis

No. Statistical Analysis

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