Qualification and Validation
Sets out the principles of qualification and validation applicable to facilities, equipment, utilities, and processes used in the manufacture of medicinal products. Introduces the lifecycle approach and continued process verification concept.
All EU GMP-regulated manufacturers. Applies to new and existing facilities, equipment, utilities, and manufacturing processes.
- 01Validation Master Plan (VMP) — site-level document describing validation approach and philosophy
- 02Risk-based qualification using a documented risk assessment to determine IQ/OQ/PQ scope
- 03Process validation lifecycle: design qualification, process qualification, continued verification
- 04Cleaning validation with scientifically justified limits and worst-case selection rationale
- 05Transport validation for products with defined storage requirements
- 06Change control — all changes assessed for requalification/revalidation requirements
Current version October 2015. Introduced lifecycle approach replacing older three-batch paradigm. No changes since 2015.
EU GMP Annex 15: frequently asked questions
Quick answers to common questions about EU GMP Annex 15.
What is EU GMP Annex 15?
EU GMP Annex 15 — Qualification and Validation — is a regulation issued by the European Medicines Agency (European Union). Sets out the principles of qualification and validation applicable to facilities, equipment, utilities, and processes used in the manufacture of medicinal products. Introduces the lifecycle approach and continued process verification concept.
Who does EU GMP Annex 15 apply to?
All EU GMP-regulated manufacturers. Applies to new and existing facilities, equipment, utilities, and manufacturing processes.
What are the key requirements of EU GMP Annex 15?
EMA EU GMP Annex 15 requires, among other things: Validation Master Plan (VMP) — site-level document describing validation approach and philosophy; Risk-based qualification using a documented risk assessment to determine IQ/OQ/PQ scope; Process validation lifecycle: design qualification, process qualification, continued verification; Cleaning validation with scientifically justified limits and worst-case selection rationale.
When was EU GMP Annex 15 last updated?
The current version of EU GMP Annex 15 dates from October 2015. Current version October 2015. Introduced lifecycle approach replacing older three-batch paradigm. No changes since 2015.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When EU GMP Annex 15 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.