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1、EUROPEAN COMMISSION 欧盟委员会ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL 企业与工业管理局Consumer goods 消费品Pharmaceuticals 药品Brussels, 03 February 2010 布鲁塞尔 2010.02.03ENTR/F/2/AM/an D(2010) 3374EudraLex（European Union Law On drug regulatory affairs） 欧盟药品法规The Rules Governing Medicinal Products in the European U
2、nion欧盟医药产品管理规则Volume 4卷4Good Manufacturing Practice良好生产规范Medicinal Products for Human and Veterinary Use人用和兽用医药产品Part II: Basic Requirements for Active Substances used as Starting Materials第二部分：作为起始物料的原料药的基本要求Document History 文件历史An amendment is made to Part II of the GMP Guide to incorporate对GMP指南第
3、二部分的修订是为了纳入与ICH Q9关于质量风险principles of Quality Risk Management in line with the ICH Q9管理的指南一致的质量风险管理原则。guideline on Quality Risk Management. Amendments correspond to对指南第一部分第一章有过类似的修订并在2008年2月公布过。similar changes made to Part I Chapter 1 of the Guide and publishedin February 2008. A new section on Qual
4、ity Risk Management is本版本新增加了2.19节，一个关于质量风险管理的新章节。introduced as section 2.19. The remaining sections of chapter 2 are第二章节其余部分进行了重新编号。2.21节进行了一个微小的变更，renumbered. A minor change is made to section 2.21. No other除此以外，没有其它的变更。changes have been made.September 20072007年9月Public consultation 公开咨询 April 200
5、8 until October 20082008年4月至2008年10月Adopted by the European Commission 欧盟委员会通过31 January 20102010年1月31日Deadline for coming into operation 生效日期31 July 20102010年7月31日Table of Contents 目录 1 Introduction 1简介 1.1 Objective 1.1目的 1.2 Regulatory Applicability 1.2法规适用性1.3 Scope 1.3范围2 Quality Management 2质量
6、管理2.1 Principles 2.1原则 2.2 Quality Risk Management2.2质量风险管理2.3 Responsibilities of the Quality Unit(s)2.3质量部门的职责2.4 Responsibility for Production Activities2.4生产活动的职责2.5 Internal Audits (Self-Inspection)2.5内部审计（自检）2.6 Product Quality Review 2.6产品质量回顾3 Personnel 3 人员3.1 Personnel Qualifications3.1 人员
7、资质3.2 Personnel Hygiene3.2 人员卫生3.3 Consultants 3.3 顾问4 Buildings and Facilities 4 厂房设施4.1 Design and Construction 4.1 设计和建造4.2 Utilities 4.2 公用工程4.3 Water 4.3 水4.4 Containment 4.4 限制4.5 Lighting 4.5 照明4.6 Sewage and Refuse 4.6 废水废物4.7 Sanitation and Maintenance 4.7 公共卫生及保养 5 Process Equipment 5 工艺设备
8、5.1 Design and Construction 5.1 设计和建造5.2 Equipment Maintenance and Cleaning 5.2 设备的保养和清洁5.3 Calibration 5.3 校验5.4 Computerized Systems 5.4 计算机系统6 Documentation and Records 6 文件和记录6.1 Documentation System and Specifications 6.1 文件系统与规格标准6.2 Equipment Cleaning and Use Record 6.2 设备清洁和使用记录6.3 Records o
9、f Raw Materials, Intermediates, API Labelling and Packaging Materials6.3 原料、中间产品、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)6.4 生产指令（生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)6.5批生产记录（批生产和控制记录）6.6 Laboratory Control Record
10、s6.6 实验室控制记录（批检验记录）6.7 Batch Production Record Review6.7 批生产记录审核7 Materials Management7 物料管理7.1 General Controls7.1 控制通则7.2 Receipt and Quarantine7.2 接受和待检7.3 Sampling and Testing of Incoming Production Materials7.3 到货物料的取样和检测7.4 Storage7.4 贮存7.5 Re-evaluation7.5 再评估8 Production and In-Process Contr
11、ols8 生产和过程控制8.1 Production Operations8.1 生产操作8.2 Time Limits8.2 时间限制8.3 In-process Sampling and Controls8.3 中控取样和控制8.4 Blending Batches of Intermediates or APIs8.4 中间产品和原料药的混批8.5 Contamination Control8.5 污染控制9 Packaging and Identification Labelling of APIs and Intermediates9 中间产品和原料药的包装和贴签9.1 Genera
12、l9.1 总则9.2 Packaging Materials9.2 包装材料9.3 Label Issuance and Control9.3 标签放行和控制9.4 Packaging and Labelling Operations9.4 包装和贴签操作10 Storage and Distribution10 贮存和销售10.1 Warehousing Procedures10.1 入库程序10.2 Distribution Procedures10.2 销售程序11 Laboratory Controls11 实验室控制11.1 General Controls11.1 控制通则11.2
13、 Testing of Intermediates and APIs11.2 中间产品和原料药的检测11.3 Validation of Analytical Procedures11.3 分析方法的验证11.4 Certificates of Analysis11.4 分析报告11.5 Stability Monitoring of APIs11.5 原料药的稳定性监测11.6 Expiry and Retest Dating11.6 失效和复检日期11.7 Reserve/Retention Samples11.7 留样12 Validation12 验证12.1 Validation Policy12.1 验证方针12.2 Validation Documentation12.2 验证文件12.3 Qualification12.3 确认12.4 Approaches to Process Validation12.4 工艺验证方法12.5 Process Validation Program12.5 工艺验证计划12.6 Periodic Review of Validated Systems12.6 验证系统的定期审核12.7 Cleaning Validation12.7 清洁验证12.8 Validation of Analytical Methods12.8
