Compare ICH Q9(R1) and FDA quality systems guide

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How they are linked

ICH Q9(R1) is the risk basis for FDA quality systems guide · Source Unverified link

Side by side

	ICH Q9(R1)	FDA quality systems guide
Authority	ICH	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
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.	FDA guidance to help manufacturers use modern quality systems and risk management to meet the CGMP regulations in 21 CFR parts 210 and 211.
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)	2 Oct 2006 Final guidance issued
Source	Official text Source: ICH.	Official text Source: FDA. Public domain.

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.