INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药物注册技术要求国际协调会议 ICH HARMONISED TRIPARTITE GUIDELINE ICH 三方协调指南三方协调指南 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: 人用药物注册通用技术文件人用药物注册通用技术文件 QUALITY 质量质量 QUALITY OVERALL SUMMARY OF MODULE 2 MODULE 3 : QUALITY 模块模块 2：质量概要：质量概要 模块模块 3：质量：质量 Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH ICH 指导委员会会议 ICH 进程第 4 步 2000 年 11 月 9 日 该指南建议三方法规处采用 ICH (Numbering and Section Headers have been edited for consistency and use in e-CTD as agreed at the Washington DC Meeting, September 11-12, 2002) 2002 年 9 月 11-12 日华盛顿会议一致通过采用统一编号和标题并在 e-CTD 中使用 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. 该指南已经合格的专家工作组研究 并按照 ICH 程序经法规部协商。进程第 4 步最终草案已被欧盟、日本和美国采纳 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: 人用药物注册通用技术文件人用药物注册通用技术文件 QUALITY 质量质量 QUALITY OVERALL SUMMARY OF MODULE 2 MODULE 3 : QUALITY 模块模块 2：质量概要：质量概要 模块模块 3：质量：质量 ICH HARMONISED TRIPARTITE GUIDELINE ICH 三方协调指南三方协调指南 Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH (Numbering and Section Headers have been edited for consistency and use in e-CTD as agreed at the Washington DC Meeting, September 11-12, 2002) ICH 指导委员会会议 ICH 进程第 4 步 2000 年 11 月 9 日 该指南建议三方法规处采用 ICH 2002 年 9 月 11-12 日华盛顿会议一致通过采用统一编号和标题并在 e-CTD 中使用 TABLE OF CONTENTS 目录目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES . 6 2.3 : QUALITY OVERALL SUMMARY (QOS) . 6 INTRODUCTION . 6 2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) . 6 2.3.S.1 General Information (name, manufacturer) . 6 2.3.S.2 Manufacture (name, manufacturer) . 7 2.3.S.3 Characterisation (name, manufacturer) . 7 2.3.S.4 Control of Drug Substance (name, manufacturer) . 8 2.3.S.5 Reference Standards or Materials (name, manufacturer) . 8 2.3.S.6 Container Closure System (name, manufacturer) . 9 2.3.S.7 Stability (name, manufacturer) . 9 2.3.P DRUG PRODUCT (NAME, DOSAGE FORM) . 9 2.3.P.1 Description and Composition of the Drug Product (name, dosage form) . 9 2.3.P.2 Pharmaceutical Development (name, dosage form) . 9 2.3.P.3 Manufacture (name, dosage form) . 9 2.3.P.4 Control of Excipients (name, dosage form) . 10 2.3.P.5 Control of Drug Product (name, dosage form) . 10 2.3.P.6 Reference Standards or Materials (name, dosage form) . 10 2.3.P.7 Container Closure System (name, dosage form) . 10 2.3.P.8 Stability (name, dosage form) . 10 2.3.A APPENDICES . 12 2.3.A.1 Facilities and Equipment (name, manufacturer) . 12 2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer) . 12 2.3.A.3 Excipients . 12 2.3.R REGIONAL INFORMATION . 12 MODULE 3 : QUALITY . 13 3.1. TABLE OF CONTENTS OF MODULE 3 . 13 3.2. BODY OF DATA .