Transcription of 품질 리스크 관리 - gmpeye.co.kr
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품질 리스크 관리 - gmpeye.co.kr
ICH Q9 Quality Risk Management GI002C gggmmmpppeeeyyyeee 1 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. ICH Q9 Quality Risk Management GI002C gggmmmpppeeeyyyeee 2 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 22 March 2005 Q9 Q9 Approval by the Steering Committee of Post Step 2 correction 15 June 2005 Q9 Current
ICH Q9 Quality Risk Management GI002C ggmmppeeyyee www.gmpeye.co.kr 2 Q9 Document History First Codification History Date New Codification November 2005 Q9 …
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