The term "qualification" in the GxP environment refers to the process of verifying the suitability of a device, facility, or system for its intended purpose. The first mention of "qualification" in GxP regulations is hard to pinpoint, but it is traced back to the late 1970s when the FDA introduced validation as part of Good Manufacturing Practice (GMP). This process includes Design, Installation, Operational, and Performance Qualifications (DQ, IQ, OQ, PQ). The exact qualification process may vary depending on the context and specific device or system. Qualification is divided into individual executable steps. It is a component of validation and relates to the performance and characteristics of systems, equipment, instruments, facilities, and software. It typically includes the following steps:
- URS (User Requirement Specification): Document that captures and defines the requirements for a specific system or product.
- DQ (Design Qualification): Verification process that confirms the design of the equipment or system meets all predefined requirements for the intended purpose.
- FAT/SAT (Factory Acceptance Test/Site Acceptance Test): FAT is a pre-shipment test process conducted at the manufacturer's site to confirm the design and operational compliance of the system. SAT validates the correct installation and functional performance of the system at the customer's site before full operation commenced.
- IQ (Installation Qualification): Verification that the equipment or system is installed correctly and functions within the planned parameters in the intended environment.
- OQ (Operational Qualification): Verification that the equipment or system operates as intended throughout the entire operational range in its specific environment.
- PQ (Performance Qualification): Confirmation and documentation that the equipment or system can consistently perform according to the parameters defined in the URS (User Requirement Specifications)