INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE QUALITY RISK MANAGEMENT Q9(R1)
Final version Adopted on 18 January 2023
The ICH Q9(R1) Guideline reached Step 4 of the ICH process on 18 January 2023.
The ICH Q9(R1) Quality Risk Management Guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality and make limited and specific adjustments to specific chapters and annexes of the current ICH Q9 Guideline on Quality Risk Management (QRM).
Further to reaching Step 4 Guideline adoption, the WG continues to work to develop specific training materials (with examples) to supplement the existing ICH briefing pack on ICH Q9, as well as to explain and facilitate the implementation and application of the proposed revisions.