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Performance Qualification (PQ) performed after successful completion of the Installation and Operational Qualifications execution, for those critical systems or processes requiring PQ that should be validated to provide assurance of process repeatability.
One of the purposes of PQ is to test the ability of the system or process to perform the intended function (over time)within the defined upper and lower process variable limits.
It is important that if OQ could be executed for system component, PQ always must be done for complete system.
The PQ protocol integrates procedures, personnel, materials, equipment, and process. PQ studies are performed for such things as steam sterilization, critical utility systems (HVAC, Purified USP water system) and cleaning and sanitization.
Test objectives, methodologies, and acceptance criteria are defined prior to execution of the PQ. A sufficient number of replicate studies performed to demonstrate the ability of the system/equipment to achieve reproducible results. Testing may include analysis for chemical, physical, and microbiological constituents.
Any exceptional conditions encountered during the PQ will be identified, investigated, and documented (including justification, correction, and any necessary re-qualification studies).
