EU GMP Annex 22
EU GMP Annex 22 (“Artificial Intelligence”) is the planned AI annex to the EU GMP guideline (EudraLex Volume 4) – the first standalone set of rules for AI models in the manufacture of medicinal products and active substances, designed as a supplement to Annex 11. The draft (consultation July to October 2025) covers, in critical applications, only static machine-learning models with deterministic output; it does not apply to generative AI and LLMs, and they should not be used in critical GMP applications. The order of evidence remains two-tiered: the surrounding computerized system is validated under Annex 11 – the evidence for the embedded model (intended use, acceptance criteria, independent test data, explainability, confidence, operation) is added by Annex 22. Whether this technology boundary survives into the final text is the most commented-on point of the consultation.
See also: EU GMP Annex 11, AI model, AI system, Intended Use.
