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TEMPLATE FOR PERFORMANCE QUALIFICATION PROTOCOL
CONTENTS
| Topic No. | Topic |
| Protocol Preparation and Approval | |
| 1.0 | Objective |
| 2.0 | Scope |
| 3.0 | Responsibility |
| 4.0 | Abbreviations & Definitions |
| 5.0 | Brief Description of Equipment |
| 6.0 | Pre-requisites |
| 7.0 | Validation Procedure |
| 8.0 | Recording/ Data compilation |
| 9.0 | Deviations and Investigations |
| 10.0 | Qualification/ Validation Report Preparation |
| 11.0 | Re-validation/Re-qualification of Equipment |
| 12.0 | Reference |
Protocol Preparation and Approval
OBJECTIVE
To describe the Performance Qualification procedure to be used during qualification of NAME OF THE EQUIPMENT system in order to:
ensure the system reproducibility over an appropriate time period as per user requirement specifications No.
Ensure that the system is showing consistency in producing Product of pre-established specifications.
SCOPE
This procedure applies to the Performance Qualification of NAME OF THE EQUIPMENT installed in pharmaceutical Company Name with Location.
RESPONSIBILITY
Validation team shall be responsible for the preparation and checking of the Performance Qualification/Validation protocol.
Head-Production, Head-Quality Control & Head-Quality Assurance shall be responsible for the approval of Performance Qualification protocol.
Head -Quality Control shall be responsible for facilitating analysis of samples,evaluations of the test results.
Production Department shall be responsible for compilation of validation data.
Head -Quality Assurance shall be responsible for approval of the Performance Qualification Report and certification after successful qualification of Equipment.
ABBREVIATIONS AND DEFINITIONS
PQ: Performance Qualification; documented verification that the integrated system or subsystem functions as intended, in its normal operating environment.
DQ: Design Qualification.
IQ: Installation Qualification.
OQ: Operational Qualification
Validation Team:Trained representatives from Quality Assurance, Quality Control, and Engineering and Production departments participating in validation. For NAME OF THE EQUIPMENT, the validation team members shall enlist their names & signatures.
BRIEF DESCRIPTION OF NAME OF THE EQUIPMENT :
Equipment ID No.
Name of the Supplier
Capacity
Location
PRE-REQUISITES
Before validating the NAME OF THE EQUIPMENT following should be ensured:
Successful completion of Operational Qualification of NAME OF THE EQUIPMENT – as per Protocol.
Availability of Test Protocols
Availability of following SOP(s)
Operation of NAME OF THE EQUIPMENT, SOP No
Cleaning of NAME OF THE EQUIPMENT, SOP No
VALIDATION PROCEDURE
Performance of the NAME OF THE EQUIPMENT shall be checked by carrying out ‘3’ batches of ‘1’ product as per their respective BMR.
Following are the critical process and quality parameters shall be noted down during the execution of the batches.
Sampling plan shall be as per the first three Process validation protocol.
RECORDING/ DATA COMPILATION
During validation study the Data from each phase shall be compiled by Validation Team.
DEVIATIONS AND INVESTIGATIONS
In case there is any deviation followed during any stage of validation, corrective action shall be taken after proper investigation. Deviations shall be recorded in Annexure-.
QUALIFICATION/ VALIDATION REPORT PREPARATION
After completion of validation, a report shall be prepared by the validation team members supported with tabulated data and statistical analysis (trending and graphical presentation of data if applicable). Performance Qualification Report shall include various components compiled in following sequence: (Note: The following components are attached as separate annexure.
Validation Report cover page
Index page for Validation Report
Approval Sheet
Name of validation team members
Parameter recording sheet
Deviations and Investigations, if any
Qualification Reports
Certification of completion of validation
RE-VALIDATION/ RE-QUALIFICATION CRITERIA
After completion of Performance qualification study, frequency of re-qualification or re-validation of NAME OF THE EQUIPMENT shall be fixed. Moreover the NAME OF THE EQUIPMENT shall invite revalidation as and when any major modification(s) is/ are done. Any change in NAME OF THE EQUIPMENT shall be executed through change control procedure as per SOP titled ‘Change Control’.
REFERENCES
User Requirement Specifications (Doc Number)
Design Qualification (Doc Number)
Installation Qualification (Doc Number).
Operational Qualification (Doc Number)
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