Compare Chapter 4 revision and Annex 11 revision

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Chapter 4 revision complements Annex 11 revision · Source Unverified link

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	Chapter 4 revision	Annex 11 revision
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.	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.
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)
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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