PQ (Performance Qualification)

PURPOSE
PQ is to verify that the system performance satisfies all requirements including the critical quality attributes and critical process parameters, that have been identified by the Quality Risk Assessment, as specified in the URS (User Requirements Specification). The performance requirements and acceptance criteria are defined in the PQ protocol for the systems requiring GMP compliance such as the clean utility systems, HVAC and cleanroom systems, and sterilizers. (The performance of the process systems and cleaning systems will be verified in the process validation and cleaning validation that are not in the scope of this PQ). The performance tests will be made under the actual production conditions, and the verification data will be collected and attached to this PQ report. PQ is the final step to formally test and document proper performance of the system prior to normal operation. When the final PQ report is approved, the system is ready for normal production operation. 

PQ PROTOCOLS
        CLEAN UTILITY SYSTEMS
                USP Purified Water Storage and Distribution Systems
                WFI Storage and Distribution Systems
                Clean Steam Generation and Distribution Systems

        SUPPORT SYSTEMS
                Autoclaves

        HVAC SYSTEMS AND CLEANROOMS
                HVAC Systems
                Cleanrooms - Aseptic
                Air Locks - Gowning