Commissioning gives biopharmaceutical companies the opportunity to work out the kinks in their equipment prior to qualification for GMP activities. However, companies make the mistake of skipping the commissioning phase. After vendor startup of equipment or after a minimum of air test and balance and room walkthroughs for a facility, companies head straight into qualification without analyzing true functionality, usability, and documentation of the system. Commissioning allows companies to test in a more relaxed state, with a running punch list, and creates an environment in which to tweak and hone the equipment, system, or facility.
The convenience and cost savings of remediating issues at the factory is key to success.
Factory Acceptance Testing (FAT) is essential for customized or complex equipment. It provides companies with the assurance that the system has been designed to their requirements and specifications prior to shipping the system to their facility.
Start-up and Site Acceptance Testing (SAT) allows you to challenge the system in your production environment and observe performance prior to qualification. The standing joke is that a system works because it is “qualified.” Qualification simply documents the GMP state of the system but not the functionality. The system function is driven by robust commissioning in a safe space to allow for improvement and fine tuning. Commissioning is a time to test components, interactions, messaging, usability, and allows design improvements before setting operation and performance requirements in stone (qualification phase).
Commissioning is a vital precursor to the qualification process.
Commissioning gives companies time test the system thoroughly to ensure critical component and alarm lists are accurate, alarm messages are correct, intercommunications and utilities are functional, software is debugged, electrical cabinets are properly labeled, spare parts lists are reviewed (and pared down from suggestions to reality of needs), and the like. Once a system is thoroughly vetted (a.k.a. properly commissioned), then the qualification phase (IQ/OQ/PQ) can focus on critical, direct impact, and GMP items with little to no deviations and help ensure complete validation of the system.
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