Compare ICH Q9(R1) and Annex 15

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How they are linked

ICH Q9(R1) is the risk basis for Annex 15 · Source Unverified link

Side by side

	ICH Q9(R1)	Annex 15
Authority	ICH	European Commission
Legal weight	Guidance & Q&A	GMP guide & annexes
Status	Final	In force
Last verified	Not yet	Not yet
Summary	The international guideline on quality risk management. It is the basis for scaling validation effort to risk in Annex 11, Annex 22 and computer software assurance, and the 2023 revision addresses subjectivity, formality and risk-based decision-making.	The EU GMP annex on qualification and validation.
Lifecycle	9 Nov 2005 Original Q9 reached Step 4 18 Nov 2021 Q9(R1) released for public consultation at Step 2 18 Jan 2023 Reached Step 4 (final)	1 Oct 2015 Came into operation
Source	Official text Source: ICH.	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.