ViP Definition
"Performance Qualification is the provision of documented evidence to demonstrate that a system or area is capable of consistent and reliable performance in a simulated or routine production environment."
PQ is the phase of validation where we start dealing with actual or simulated product. In the case of utilities or production environments, it comprises extensive sampling and testing for compliance with, where applicable, all predetermined physical, chemical and microbiological acceptance criteria. For stand-alone equipment, it verifies the confidence gained at OQ is justified when handling product or placebo, and, for equipment installed as part of a process or packing line, PQ verifies each installed item successfully interfaces with its upstream and downstream station(s) in delivering a product or placebo meeting all quality specifications.
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