欧洲药品GMP检查指南及附件中英文.docVIP

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP检查指南. PIC/S July 2004 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat P.O. Box 5695 CH-1211 Geneva 11 e-mail: daniel.brunner@ web site: 1 July 2004 PE 009-2 TABLE OF CONTENT目录 INTRODUCTION介绍 1 CHAPTER 1 QUALITY MANAGEMENT 质量管理 4 PRINCIPLE 原则 4 QUALITY ASSURANCE 质量保证 4 GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP) 药品GMP 6 QUALITY CONTROL 质量控制 7 CHAPTER 2 PERSONNEL 人员 10 PRINCIPLE 原则 10 GENERAL 通则 10 KEY PERSONNEL 关键人员 10 TRAINING 培训 13 PERSONAL HYGIENE 个人卫生 14 CHAPTER 3 PREMISES AND EQUIPMENT 厂房和设备 16 PRINCIPLE 原则 16 PREMISES General总则 16 Production Area 生产区域 17 Storage Areas 储存区域 19 Quality Control Areas 质量控制区域 20 Ancillary Areas 辅助区域 20 EQUIPMENT 设备 21 CHAPTER 4 DOCUMENTATION 文件 23 PRINCIPLE 原则 23 GENERAL 总则 23 DOCUMENTS REQUIRED 必需的文件 25 MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS 生产方法和加工指示 27 PACKAGING INSTRUCTIONS 包装指示 28 BATCH PROCESSING RECORDS 批加工记录 29 BATCH PACKAGING RECORDS 批包装记录 30 PROCEDURES AND RECORDS 程序和记录 32 CHAPTER 5 PRODUCTION 生产 36 PRINCIPLE 原则 36 GENERAL 通则 36 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 生产过程中防止交叉污染 38 VALIDATION 验证 39 STARTING MATERIALS 起始物料 40 PROCESSING OPERATIONS - INTERMEDIATE AND BULK PRODUCTS 加工操作：中间体和散装产品 42 PACKAGING MATERIALS 包装材料 42 PACKAGING OPERATIONS 包装操作 43 FINISHED PRODUCTS 最终成品 45 REJECTED, RECOVERED AND RETURNED MATERIALS 拒绝的，回收的和退回的物料 46 CHAPTER 6 QUALITY CONTROL 质量控制 48 PRINCIPLE 原则 48 GENERAL 通则 48 GOOD QUALITY CONTROL LABORATORY PRACTICE 优良质量控制实验室实践 49 DOCUMENTATION 文件 49 SAMPLING 取样 50 TESTING 检测 52 CHAPTER 7 CONTRACT MANUFACTURE AND ANALYSIS 合同加工和分析 55 PRINCIPLE 原则 55 GENERAL 通则 55 THE CONTRACT GIVER 合同提供人 55 THE CONTRACT ACCEPTOR 合同接受人 56 THE CONTRACT 合同 57 CHAPTER 8 COMPLAINTS AND PRODUCT RECALL 抱怨和产品召回 59 PRINCIPLE 原则 59 COMPLAINTS 抱怨 59 RECALLS 召回 60 CHAPTER 9 SELF INSPECTION 自检 61 PRINCIPLE 原则 61 ANNEX