Q10 药物质量体系20080604(中英文).doc

Q10 药物质量体中英文）?? ? ?INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE ICH三方协调指南 PHARMACEUTICAL QUALITY SYSTEM 药物质量体系 Q10 Current Step 4 version dated 4 June 2008 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. ? Q10 Document History 文件历史 Code History Date Q10 Approved by the Steering Committee under Step 2 and release for public consultation. 9 May 2007 Current Step 4 version Code History Date Q10 Approved by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 4 June 2008 ? ?  PHARMACEUTICAL QUALITY SYSTEM ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 4 June 2008, this guideline is recommended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 1. PHARMACEUTICAL QUALITY SYSTEM..........................................................1 1.1 Introduction................................................................................................................1 1.2 Scope..........................................................................................................................1 1.3 Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards and ICH Q7.............2 1.4 Relationship of ICH Q10 to Regulatory Approaches................................................2 1.5 ICH Q10 Objectives....................................................................................................2 1.5.1 Achieve Product Realisation..........................................................................2 1.5.2 Establis