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.
Purpose and Scope The facility qualification lifecycle provides the documented framework for demonstrating that a GMP facility is suitable for its intended use and remains in a controlled condition throughout its operational life. The lifecycle begins before construction. Product, process,…
Purpose and Scope Facility Design Qualification provides documented evidence that a proposed GMP facility design is suitable for its intended use, satisfies approved requirements, and adequately controls identified quality and operational risks before the design is accepted for construction. Facility…
Purpose and Scope Facility Installation Qualification provides documented evidence that the as-built GMP facility conforms to approved requirements, drawings, specifications, design decisions, and applicable installation standards. Facility IQ verifies the installed condition. It determines whether rooms, architectural features, facility systems,…
Purpose and Scope Facility Operational Qualification provides documented evidence that integrated facility functions operate as intended throughout approved operating ranges and respond correctly to defined challenge, alarm, failure, emergency, and recovery conditions. Facility OQ evaluates the facility as a coordinated…
Purpose and Scope Facility periodic review is a structured, documented assessment used to determine whether a GMP facility remains suitable for its approved intended use and continues to operate in a qualified state. The review evaluates the facility as an…