欧洲药品GMP检查指南.doc

GUIDE TO GOOD MANUFACTURING
PRACTICE FOR MEDICINAL PRODUCTS
药品GMP检查指南.
PIC/S July 2004
Reproduction prohibited mercial purposes.
Reproduction for internal use is authorised,
provided that the source is acknowledged.
Editor: PIC/S Secretariat
. Box 5695
CH-1211 Geneva 11
e-mail: @
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 PLAINTS AND PRODUCT RECALL 抱怨和产品召回 59
PRINCIPLE 原则 59
COMPLAINTS 抱怨 59
RECALLS 召回 6