This category describes the facility qualification lifecycle from design through performance qualification, requalification, and periodic review. It outlines qualification strategies, documentation expectations, and lifecycle management needed to demonstrate and maintain facility control.
Requalification and periodic review ensure that a GMP facility remains in a state of control after initial qualification. These activities recognize that facilities change over time due to aging, operational use, maintenance activities, and formal modifications. Initial qualification alone is not sufficient to demonstrate ongoing compliance. For facilities, requalification is not automatic or time-based by…
Facility Operational Qualification establishes documented evidence that facility systems operate within defined limits and respond as intended under controlled conditions. For facilities, OQ demonstrates that installed systems can be operated in a compliant manner and that critical controls, alarms, and interlocks function as designed. Operational Qualification does not assess long-term performance or routine monitoring results….
Facility Installation Qualification establishes documented evidence that facility systems, components, and utilities are installed in accordance with the approved design and specifications. For facilities, IQ confirms that design intent has been implemented correctly and that the as-built condition is suitable to support controlled operation. Installation Qualification does not assess how systems operate. Its purpose is…
Facility Design Qualification establishes documented evidence that a GMP facility is designed to be fit for its intended use and capable of supporting coFacility Design Qualification establishes that a GMP facility is designed to support compliant operations throughout its lifecycle. For facilities, DQ is not inherently a standalone protocol. It is a structured evaluation of…
The facility qualification lifecycle defines the structured approach used to ensure that a GMP facility is designed correctly, constructed as intended, and operated in a controlled manner suitable for its intended use. For facilities, qualification is not a single event or a fixed sequence of documents. It is a lifecycle framework that begins with design…
