04.13.23 -- ICH's New Q9(R1) Guideline On Quality Risk Management: A Primer

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The long-awaited revision to ICH’s harmonized tripartite guidance on quality risk management (QRM), Q9(R1), was adopted on January 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

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