What is Commissioning?
Commissioning is a systematic approach to the start-up and turnover of facilities, systems, and equipment to end-users and ensuring that user requirements and design specifications are met (International Society of Pharmaceutical Engineering [ISPE]).
Activities within this phase may include design reviews, factory acceptance testing, site acceptance testing, installation verification, and functional testing. Summary reports are generated at the conclusion of commissioning activities and include an overview of the results and any deviations encountered during testing. Commissioning, if well documented, may be leveraged to reduce or eliminate qualification testing.