FDA quality systems guide and its 2 linked instruments

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Details: Guide Definitions: every term and label explained

	FDA quality systems guide	21 CFR Part 211	ICH Q9(R1)
Authority	FDA	FDA	ICH
Legal weight	Guidance & Q&A	Law & regulation	Guidance & Q&A
Status	Final	In force	Final
Last verified	Not yet	Not yet	Not yet
Summary	FDA guidance to help manufacturers use modern quality systems and risk management to meet the CGMP regulations in 21 CFR parts 210 and 211.	US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data.	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.
Lifecycle	2 Oct 2006 Final guidance issued	29 Sep 1978 Published at 43 FR 45077	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)
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.	Official text Source: ICH.

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.