Transcription of QUALITY RISK MANAGEMENT - ICH
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QUALITY RISK MANAGEMENT - ICH
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE QUALITY RISK MANAGEMENT Q9 Current Step 4 version dated 9 November 2005 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. Q9 Document History First Codification History Date New Codification November 2005 Q9 Approval by the Steering Committee under Step 2 and release for public consultation.
diagram (Figure 1). Other models could be used. The emphasis on each component of the framework might differ from case to case but a robust process will incorporate consideration of all the elements at a level of detail that is commensurate with the specific risk. Figure 1: Overview of a typical quality risk management process Risk Review
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