Compare ICH Q10 and ICH Q9(R1)

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How they are linked

ICH Q10 complements ICH Q9(R1) · Source Unverified link

Side by side

	ICH Q10	ICH Q9(R1)
Authority	ICH	ICH
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
Last verified	Not yet	Not yet
Summary	ICH model for an effective quality management system for the pharmaceutical industry.	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	8 Apr 2009 Published by FDA as guidance	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: ICH.	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.