ichq7中英文资料.pdf

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7 Current Step 4 version dated 10 November 2000 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. 中英文对照 中英文对照 Q7 Q7 Document History First Codification History Date New Codification November 2005 Q7A Approval by the Steering Committee under Step 2 and release for public consultation. 19 July 2000 Q7 Current Step 4 version Q7A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 10 November 2000 Q7 GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH Table of Contents 目录 1. INTRODUCTION 1. 前言 1.1 Objective 1.1 目的 1.2 Regulatory Applicability 1.2 法规的适用性 1.3 Scope 1.3 范围 2. QUALITY MANAGEMENT 2.质量管理 2.1 Principles 2.1 总则 2.2 Responsibilities of the Quality Unit(s) 2.2 质量部门的责任 2.3 Responsibility for Production Activities 2.3 生产的职责 2.4 Internal Audits (Self Inspection) 2.4 内部审计（自检） 2.5 Product Quality Review 2.5 产品质量回顾 3. PERSONNEL 3. 人员 3.1 Personnel Qualifications 3.1人员资格 3.2 Personnel Hygiene 3.2 个人卫生 3.3 Consultants 3.3 顾问 4. BUILDINGS AND FACILITIES 4. 建筑和设施 4.1 Design and Construction 4.1 设计和建造 4.2 Utilities 4.2 公用设施 4.3 Water 4.3 水 4.4 Containment 4.4 特殊限制 4.5 Lighting 4.5 照明 4.6 Sewage and Refuse 4.6 污物和废弃物 4.7 Sanitation and Maintenance 4.7 卫生和维护 5. PROCESS EQUIPMENT 5. 工艺设备 5.1 Design and Construction 5.1 设计和建造 5.2 Equipment Maintenance and Cleaning 5.2 设备维护和清洁 5.3 Calibration 5.3 校验 5.4 Computerized Systems 5.4 计算机控制系统 6. DOCUMENTATION AND RECORDS 6. 文件和记录 6.1 Documentation System and Specifications 6.1 文件系统和质量标准 6.2 Equipment cleaning and Use Record 6.2 设备的清洁和使用记录 6.3 Records of Raw Materials,Intermediates, 6.3 原料、中间体、原料药的标签和包装材料的记录 API Labeling and Packaging Materials 6.4 Master Production Instructions 6.4 主生产指令（主生产和控制记录） (Master Production and Control Records) 6.5 Batch Production Records 6.5 批生产记录（批生产和控制记录） (BatchProduction and Control Records) 6.6 Laboratory Control Records 6.6 实验室控制记录 6.7 Batch Production Record Review 6.7 批生产记录审核 7. MATERIALS MANAGEMENT 7. 物料管理 7.1 General Controls 7.1 一般要求 7.2 Receipt and Quarantine 7.2 接收和待验 7.3 Sampling and Testing of Incoming Production Materials 7.3 来料的取样与检测 7.4 Storage 7.4 储存 7.5 Re-evaluation 7.5 再评价 8. PRODUCTION AND IN-PROCESS CONTROLS 8. 生产管理和生产过程控制 8.1 Production Operations 8.1 生产管理 8.2 Time Limits 8.2 时限 8.3 In-process Sampling and Controls 8.3 生产过程中的取样和控制 8.4 Blending Batches of Intermediates or APIs 8.4 中间体或原料药的混批 8.5 Contamination Control 8.5 污染控制 9. PACKAGING AND IDENTIFICATION 9. 原料药和中间体的包装和贴签 LABELING OF APIs AND INTERMEDIATES 9.1 General 9.1 通则 9.2 Packaging Materials 9.2 包装材料 9.3 Label Issuance and Control 9.3 标签发放与管理 9.4 Packaging and Labeling Operations 9.4 包装和贴签管理 10. STORAGE AND DISTRIBUTION 10.储存和分发 10.1 Warehousing Procedures 10.1 入库程序 10.2 Distribution Procedures 10.2 分发程序 11. LABORATORY CONTROLS 11.实验室管理 11.1 General Controls 11.1通则 11.2 Testing of Intermediates and APIs 11.2 中间体和原料药的检测 11.3 Validation of Analytical Procedures 11.3 分析方法的验证 11.4 Certificates of Analysis 11.4 检验报告 11.5 Stability Monitoring of APIs 11.5 原料药的稳定性考察 11.6 Expiry and Retest Dating 11.6 有效期和复验期 11.7 Reserve/Retention Samples 11.7 留样 12. VALIDATION 12.验证 12.1 Validation Policy 12.1 验证方针 12。