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.
Risk analysis is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms. In some risk management tools, the ability to detect the harm
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