TEMPLATE FOR PERFORMANCE QUALIFICATION PROTOCOL
|Topic No.||Topic||Page No.|
|Protocol Preparation and Approval||2|
|4.0||Abbreviations & Definitions||3|
|5.0||Brief Description of Equipment||4|
|8.0||Recording/ Data compilation||5|
|9.0||Deviations and Investigations||5|
|10.0||Qualification/ Validation Report Preparation||5|
|11.0||Re-validation/Re-qualification of Equipment||5|
Protocol Preparation and Approval
Preparation and Checking:
|Prepared by||Checked by|
|Department||Quality Assurance||Quality Control||Production||Production||Quality Control||Quality Assurance|
|Head-Production||Head- Quality Control||Head- Quality Assurance|
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.
This procedure applies to the Performance Qualification of NAME OF THE EQUIPMENT installed in pharmaceutical Company Name with Location.
- 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|
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’.
- User Requirement Specifications (Doc Number)
- Design Qualification (Doc Number)
- Installation Qualification (Doc Number).
- Operational Qualification (Doc Number)
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube