Performance Qualification Protocols

Performance Qualification (PQ) verifies the performance of critical utility systems or processes. Critical utility systems such as WFI and Pure Steam are challenged throughout proposed operating ranges for extended periods of time, while an extensive program of quality monitoring is performed. Critical processes such as sterilization of components are challenged three (3) consecutive times under worst-case conditions. 

Performance Qualification is carried out in accordance with a preapproved written protocol. The specific PQ attributes to be verified during the performance of the protocol will be developed from the finished product specifications, research and development data, cGMP requirements, and other specific documentation. They, along with the acceptance criteria, will be approved as part of the protocol approval process. 

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A specific performance qualification protocol shall be prepared for each piece of equipment undergoing performance qualification. The performance qualification of the computerized system consists of accumulating enough evidence that the computerized system is in compliance with its intended specifications, when functioning for the concerned process at the production premises. 

Vial/Ampoule Washer Performance Qualification Protocol... 

The purpose is to describe the format and contents of the stopper sterilization performance qualification protocol. 

Performance qualification can be done on equipment even if it has been in use for some time. The performance qualification protocol should describe how the performance of the equipment is to be demonstrated. If this involves a trial batch, then the composition of the batch should be described. The protocol should also describe how the equipment would be used to process the trial material. Finally the protocol should delineate the expected output that will show the equipment performs as... 

Once the system performance qualification protocol has been completed, the test results, data, and documentation are formally evaluated. The written evaluation should be presented clearly and in a manner that can be readily understood. The structure of the report can parallel the structure of the associated protocol. The report should also address any nonconformances encountered during the system operational qualification and their resolution. The system performance qualification report summarizes the results of the verification and testing of all technologies that are part of the integrated system. 

Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol. 

Responsibility Person responsible for operating the system or equipment will perform the qualification and record the information. The supervisor will supervise the study, verity the completion of the records and write the Deviation Report and the Performance Qualification Report. Quality Assurance will review and approve the Performance Qualification Protocol and Report. 

QA006 Performance qualification protocol format and requirements for software... 

IQ Installation Qualification protocol OQ Operational Qualification protocol PQ Performance Qualification protocol PV Process Validation protocol PM Preventive Maintenance procedure... 

This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as a guideline for those involved in the validation of ABC Pharmaceutical. Approval of this Master Plan neither provides approval of these test functions and acceptance criteria nor does it limit the test functions and acceptance criteria included in any protocol. Final approval of test functions and acceptance criteria is made by approval of the Installation, Operational, and where applicable, Performance Qualification protocols. 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

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