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
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Annex 22 and AI in validation documentation
The draft of EU GMP Annex 22, published for consultation in July 2025 and not yet binding, expects AI in GMP to have a defined intended use, validation and change control, human oversight of outputs, and data transparency. For documentation this means output stays a draft until a qualified person reviews it, and the review is recorded.