ICH协调指导原则 Q9(R1) QUALITY RISK MANAGEMENT (2).pdf

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE QUALITY RISK MANAGEMENT Q9(R1) Draft version Endorsed on 18 November 2021 Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures. Q9(R1) Document History Q9 Code History Date Q9 Approval by the Steering Committee under Step 4 9 November 2005 and recommendation for adoption to the three ICH regulatory bodies. Revision of Q9 Code History Date Q9(R1) Endorsement by the Members of the ICH Assembly 18 November under Step 2 and release for public consultation 2021 (document dated day/month/year). Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICHs copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable