ICH Q9(R1): Quality Risk Management

ICH · Final

Last verified: not yet

Unverified: the editor has not yet checked this record against the official source.

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.

Dated events

1. 18 Jan 2023 Reached Step 4 (final) Source for Reached Step 4 (final)

Official source

Official text

Source: ICH.