Chapter 4 revision and its 3 linked instruments

How to read this page

First column: Chapter 4 revision. The others are every document linked to it.
Scroll sideways if there are more columns than fit.
It does not compare content. It does not say which is stricter. Read the official texts for that.

Details: Guide Definitions: every term and label explained

	Chapter 4 revision	Annex 11 revision	Chapter 4 (2011)	Annex 22 · AI
Authority	European Commission	European Commission	European Commission	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes	GMP guide & annexes	GMP guide & annexes
Status	Draft	Draft	In force	Draft
Last verified	Not yet	Not yet	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.	A full rewrite of Annex 11, published for consultation with the revised Chapter 4 and the new Annex 22. It expands expectations on supplier oversight, data integrity, audit trails, identity and access, cloud and outsourced services. Not yet in force: the 2011 Annex 11 still applies.	The current EU GMP chapter on documentation. Manufacturers of medicinal products must define their documents and media in the quality management system, on paper, electronically or as photographs, and keep them accurate, intact, available and legible. Revision 1 updated the sections on generating, controlling and retaining documents because of growing electronic use.	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)	16 Nov 2022 Concept paper on revising Annex 11 (EMA/INS/GMP/778340/2022) 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, slipped from Q1 2026)	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation	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.	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: European Commission. Licensed under CC BY 4.0.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.