ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Performance Qualification (PQ)

The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification

Publication Source: ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

Publication Date: 2011

Performance Qualification (PQ)

Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

Performance Qualification (PQ)

For “Direct Impact” systems - The documented verification that all aspects of a facility, utility or equipment that can affect product quality, perform as intended meeting predetermined acceptance criteria.

Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Publication Date: 2007

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