Glossary · GxP: good practices
Qualification: DQ, IQ, OQ and PQ
Also known as: Equipment qualification, Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ), IQ/OQ/PQ
Under EU GMP Annex 15, qualification is the documented proof that premises, equipment, utilities and systems are properly designed, installed and work as intended. It proceeds in stages: design qualification (DQ) against user requirements, installation qualification (IQ), operational qualification (OQ) across the intended operating ranges, and performance qualification (PQ) under routine conditions.
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In one sentence
Qualification proves that equipment, utilities and premises are fit for GMP use, in stages: DQ, IQ, OQ and PQ, based on user requirements and risk.
Example
For a new autoclave, the manufacturer checks the design against its user requirement specification (DQ), verifies installation and calibrated sensors (IQ), tests cycles at the limits of the operating ranges (OQ) and runs loaded cycles with biological indicators (PQ).
How it applies
- Starting point: A user requirement specification (URS) defines what the equipment must do; it is the reference for every later stage.
- Stages: DQ checks the design against the URS; factory and site acceptance tests may precede or feed into IQ; IQ checks correct installation, documentation and calibration; OQ tests functions over the operating ranges; PQ shows consistent performance with production materials or simulated loads.
- Risk-based effort: Annex 15 lets the depth of qualification follow a documented risk assessment, and allows engineering documents produced under GEP to be reused where they are adequate.
- Keeping the status: Qualified equipment stays under change control and periodic review; changes can require requalification.
- Technical documentation: Protocols with acceptance criteria are approved before execution; reports record results, deviations and the conclusion that the equipment may be released for use.
Qualification vs. validation
Qualification is done on things — premises, equipment, utilities, systems. Validation is done on processes, cleaning, analytical methods and computerized systems in use. Qualification is a precondition for validation: a process run on unqualified equipment cannot be validated.