Artificial Intelligence
Draft EudraLex Volume 4 annex setting the first GMP-specific expectations for artificial intelligence in regulated manufacture. Published 7 July 2025 by the European Commission jointly with PIC/S and consulted alongside revisions to Chapter 4 (Documentation) and Annex 11 (Computerised Systems); the consultation closed 7 October 2025. It remains a draft with no adoption date — plan against it, not to it. Until it is adopted there is no GMP-specific instrument for AI: Annex 11 remains the applicable text for computerised systems, read with ISPE GAMP 5.
Always verify against the current published text before relying on it for a submission or inspection.
Scope & applicability
Draft scope covers AI and machine-learning models used in GMP-critical applications. The draft confines itself to static, deterministic models — parameters frozen, identical inputs producing identical outputs — and excludes dynamic self-learning models, generative AI and large language models from GMP-critical use.
Key requirements
- Models in GMP-critical applications are static and deterministic — parameters frozen, identical inputs producing identical outputs
- Dynamic self-learning models, generative AI and large language models are excluded from GMP-critical applications
- Test data is independent of training data
- Artificially generated test data is advised against in critical applications unless justified and documented
Revision notes
No previous version — this is the first EU GMP annex addressing artificial intelligence. Draft published 7 July 2025; consultation closed 7 October 2025; no final text published as of 4 September 2026. Annex 11 remains the applicable text for computerised systems in the meantime. Treat every requirement here as provisional until the Commission adopts final text.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
EU GMP Annex 22: frequently asked questions
Quick answers to common questions about EU GMP Annex 22.
What is EU GMP Annex 22?
EU GMP Annex 22 — Artificial Intelligence — is a draft annex issued by the European Commission — EudraLex (European Union). Draft EudraLex Volume 4 annex setting the first GMP-specific expectations for artificial intelligence in regulated manufacture. Published 7 July 2025 by the European Commission jointly with PIC/S and consulted alongside revisions to Chapter 4 (Documentation) and Annex 11 (Computerised Systems); the consultation closed 7 October 2025. It remains a draft with no adoption date — plan against it, not to it. Until it is adopted there is no GMP-specific instrument for AI: Annex 11 remains the applicable text for computerised systems, read with ISPE GAMP 5.
Who does EU GMP Annex 22 apply to?
Draft scope covers AI and machine-learning models used in GMP-critical applications. The draft confines itself to static, deterministic models — parameters frozen, identical inputs producing identical outputs — and excludes dynamic self-learning models, generative AI and large language models from GMP-critical use.
What are the key requirements of EU GMP Annex 22?
EC EU GMP Annex 22 requires, among other things: Models in GMP-critical applications are static and deterministic — parameters frozen, identical inputs producing identical outputs; Dynamic self-learning models, generative AI and large language models are excluded from GMP-critical applications; Test data is independent of training data; Artificially generated test data is advised against in critical applications unless justified and documented.
When was EU GMP Annex 22 last updated?
The current version of EU GMP Annex 22 dates from July 2025. No previous version — this is the first EU GMP annex addressing artificial intelligence. Draft published 7 July 2025; consultation closed 7 October 2025; no final text published as of 4 September 2026. Annex 11 remains the applicable text for computerised systems in the meantime. Treat every requirement here as provisional until the Commission adopts final text.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.