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Q10 药物质量体系20080604(中英文)
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.
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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 ?
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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
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