Annex 22 — artificial intelligence in GMP

Annex 22 is a draft annex to EU GMP covering artificial intelligence in medicinal product manufacturing; it was published on 7 July 2025 and its public consultation closed on 7 October 2025. The document remains a draft and is not binding. These posts cover its status, its scope, and what it expects of documentation and model oversight. EU GMP Annex 22 (draft, 7 July 2025), status and consultation