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EU GMP Annex 15: the qualification stages explained

Annex 15 describes URS, DQ, FAT/SAT, IQ, OQ and PQ as a sequence that builds evidence a system is fit for its intended use — with requalification when things change.

ValiTrac AI editorialUpdated 2026-09-132 min read
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Annex 15 to the EU GMP guide sets out the qualification and validation expectations for facilities, equipment, utilities and systems. It frames qualification as a lifecycle: user requirements, design qualification, factory and site acceptance testing where appropriate, installation, operational and performance qualification, and ongoing requalification.

Stages

  • URS: the essential requirements the equipment must meet, including quality-critical parameters.
  • DQ: documented verification that the proposed design is suitable for the intended purpose.
  • IQ: verification that the equipment is installed correctly — components, calibration of instruments, documentation.
  • OQ: tests over the operating ranges, including upper and lower limits and worst-case conditions.
  • PQ: demonstration of consistent performance under routine use with real or simulated product.

For a temperature-controlled storage space, temperature mapping is the core of OQ (empty) and PQ (loaded).

Frequently asked questions

Can IQ and OQ be combined?
Annex 15 allows IOQ where justified, provided the requirements of both are covered and documented.
Is a risk assessment required?
Yes. Annex 15 expects a quality risk-management approach (ICH Q9) to determine the scope and extent of qualification.

References

  1. [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
  2. [2]ICH Q9(R1): Quality Risk Management

General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.

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