Compare Annex 11 revision and Annex 15

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Annex 11 revision complements Annex 15 · Source Unverified link

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	Annex 11 revision	Annex 15
Authority	European Commission	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes
Status	Draft	In force
Last verified	Not yet	Not yet
Summary	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 EU GMP annex on qualification and validation.
Lifecycle	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 Oct 2015 Came into operation
Source	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.