By Paul L Pluta

Published in: IVT Jr GXP

Published on: November 30, 2020

Introduction: A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee. ICH Q9 is a key document associated with change management and validation. The original ICH Q9 was issued more than 10 years ago. This topic was endorsed by the ICH Assembly in November 2019. Two primary activities are addressed: -Limited and specific adjustments to specific chapters and annexes in the current ICH Q9 -Specific training materials with examples to supplement current ICH Q9 and the proposed revisions. This document summarizes key points associated with the revision as expressed in ICH documents.

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