Compare Chapter 4 revision and Annex 22 · AI

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Chapter 4 revision complements Annex 22 · AI · Source Unverified link

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	Chapter 4 revision	Annex 22 · AI
Authority	European Commission	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes
Status	Draft	Draft
Last verified	Not yet	Not yet
Summary	Revised GMP documentation chapter, consulted on jointly with PIC/S. It updates expectations for records in any format, data governance and the documentation lifecycle, aligning with the revised Annex 11. Draft only.	The first EU GMP text written specifically for AI, drafted with PIC/S. It covers AI models used in GMP-critical applications and complements the revised Annex 11 and Chapter 4. Static, deterministic models may be used in critical applications, subject to validation. Dynamic models, generative AI and LLMs are kept out of critical uses in the current draft; non-critical use needs documented human oversight. Whether generative AI can be allowed with guardrails was discussed at the June 2026 workshop.
Lifecycle	7 Jul 2025 Draft published for public consultation 7 Oct 2025 Public consultation closed Target 31 Dec 2026 Target: final text to European Commission (Q4 2026)	7 Jul 2025 Draft published for public consultation 7 Oct 2025 Public consultation closed 30 Jun 2026 EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul) Target 31 Dec 2026 Target: final text to European Commission (Q4 2026)
Source	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: European Commission. Licensed under CC BY 4.0.

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