Transcription of Final Concept Paper ICH Q9(R1) - Quality Risk Management
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Final Concept Paper ICH Q9(R1) - Quality Risk Management
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Secretariat, Route de Pr -Bois 20, 1215 Geneva, Switzerland Telephone: +41 (22) 710 74 80 - Final Concept Paper ICH Q9(R1) - Quality Risk Management Endorsed by the Management Committee on 13 November 2020 Type of Harmonisation Action Proposed The following harmonization actions are proposed: 1. Limited and specific adjustments would be made to specific chapters and annexes of the current ICH Q9 Guideline on Quality Risk Management (QRM).
complex problems, which usually require increased levels of rigour and effort. It is considered that a greater understanding of formality in QRM has the potential to lead to more appropriate and beneficial uses of QRM, leading to improved outcomes in terms of pharmaceutical quality, medicine availability, and patient protection.
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