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Template for Performace Qualification Protocol

  • OBJECTIVE
  • To describe the Performance Qualification procedure to be used during qualification of NAME OF THE EQUIPMENT system in order to:
  • Ensure the system reproducible over an appropriate time period as per user requirement specifications
  • 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 Production.
  • 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 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.
  • Availability of Test Protocols
  • Availability of following SOP(s)
  • Operation of NAME OF THE EQUIPMENT, SOP
  • Cleaning of NAME OF THE EQUIPMENT, SOP
  • 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.
  • 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). Performance Qualification Report shall include various components compiled in following sequence: (Note: The following components are attached.
  • 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

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  • RE-VALIDATION/ RE-QUALIFICATION 

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 re-validation 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.
  • Design Qualification).
  • Installation Qualification.
  • Operational Qualification.

 

 

 

 

 

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