QUALIFICATION is a process that extends beyond commissioning because it is primarily concerned with verifying facility and system aspects that can affect product quality. Facilities Qualification validates the overall manufacturing / testing / production environment. The requirement of a facility qualification is driven by the processes performed in a room and whether the processes define specific requirements for the spaces.

All equipment and utilities used in the process area must be listed in the Facilities Qualification, along with reference to the validation documents generated during their qualification.