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1、2018年3月17日,Pharmaceutical Services Corporation美国医药服务有限公司,How GMPs are regulated in Europe欧洲药品生产管理规范,What Is GMP?什么是GMP？,Definition:定义：The part of Quality Assurance which ensures products are consistently produced and controlled in accordance with the quality standards appropriate for their intended
2、use 质量保证的一部分，它确保按产品预定用途持续稳定地控制生产，保证产品符合质量标准要求。,2,What Is GMP?什么是GMP？,The procedures employed to ensure that the drug product or substance is manufactured under a quality management system and meets the claimed requirements for purity, identity, safety and quality 遵循标准操作规程，以确保药品的生产在质量管理系统的控制中并符合注册的纯度
3、、鉴别、安全和质量Continuously evolving “feasible and valuable” industry practices designed to ensure the above 持续地发展“可行性和有用性”的工业规范，以确保达到以上要求,3,A Brief History of GMPGMP历史简介,1962 The food drug and cosmetic act requires that drugs must be made in accordance with good manufacturing practices 食品、药品和化妆品法要求药品必须符合
4、药品生产管理规范1969 WHO publishes Good Practices in the Manufacture and Quality control of drugs 世界卫生组织出版了药品生产和质量控制的管理规范1971 The guide to good pharmaceutical manufacturing practice (orange guide) published 药品生产管理规范指南(orange guide)出版英国GMP1976 FDA publishes proposed cGMPS 美国食品药物管理局出版了提议的药品生产管理规范,4,A Brief Hi
5、story of GMPGMP历史简介,1978 Major revision in FDA 21 CFR 210 and 211. 美国食品药物管理局的21 CFR 210 和 211重大版本变更1989 European guide to GMP published 欧盟出版药品生产管理规范指南1991 European commission adopts two directives on principles and guidelines for GMP 欧洲委员会在药品生产管理规范原则和指南上采用两种条令1992 European guide to GMP revised. Furt
6、her annexes added. Some Chapters revised 2008 欧洲药品生产管理规范指南更新，添加了新的附录。2008 年更新了一些章节。2003 Commission Directive replaced by 2003/94/EC 欧洲委员会条令由2003/94/EC取代,5,GMP VariationsGMP的差异,The overall principles of Good Manufacturing Practice are similar whether we follow the WHO Guidelines, the EU Guidelines or
7、 the FDA guidelines 不管是世界卫生组织指南、欧洲指南，还是美国食品药物管理局指南，药品生产管理规范的总体原则是相似的There are numerous variations in the application of these principles 这些原则在应用上有些差异The enforcement of the guidelines varies between different regulatory authorities 不同法规组织在指南的实施上存在差异The approach taken by individual inspectors varies 不
8、同检查人员所采用的方法存在差异The approach taken by different regulatory authorities varies 不同法规组织所采用的方法存在差异,6,The GMPs tell us what to do, they do not tell us how to do it. 药品生产管理规范告诉我们做什么，而不告诉我们怎样做。 How comes from: 怎样来源于：industry standard practice and guidelines 工业标准规范和指南,7,Commission Directive 2003/94/EC委员会条令20
9、03/94/EC,Replaced original directive 91/356/EEC 替代原有条令91/356/EECLays down principles and guidelines of GMP for medicinal products for human use 规定了人用药品的生产管理规范的原则和指南Member states must ensure respect for GMP by means of repeated inspections 通过反复检查，成员国必须确保遵守药品生产管理规范Interpretation of Principles and guid
10、elines shall be by reference to the “Guide for good manufacturing practice for medicinal products and for investigational medicinal products” 原则和指南的解释应参考“药品和在研药品的生产管理规范指南”,8,Commission Directive 2003/94/EC委员会条令2003/94/EC,For products imported from third country, the importer shall ensure products ar
11、e manufactured to a standard at least equivalent to GMP as laid down by EU 由第三国进口的药品，进口商要确保药品的生产达到至少等同于欧盟规定的药品生产管理规范Importer shall ensure that products have been manufactured by authorised manufacturers 进口商要确保药品是授权生产厂家生产的Must be manufactured in compliance with Marketing Authorisation 药品的生产必须符合药品注册批准
12、的要求。,9,Commission Directive 2003/94/EC委员会条令2003/94/EC,The rest of the Directive briefly summarises the aspects of GMP that must be in place. These are addressed in more detail in the GMP Guide. 条令的其余部分总结了药品生产管理规范必须执行的方面。这些在药品生产管理规范指南中有更详细地说明。,10,EU Guidelines to GMP欧洲GMP指南,Published as Vol 4 of Eudr
13、aLex by the EuropeanCommission由欧洲委员会出版，共4卷。 This comprises:这包括：Introduction 引言Chapter 1 Quality Management 第一章 质量管理Chapter 2 Personnel 第二章 人员Chapter 3 Premises and Equipment 第三章 厂房和设备,11,EU Guidelines to GMP欧洲GMP指南,Chapter 4 Documentation 第四章 文件Chapter 5 Production 第五章 生产Chapter 6 Quality Control 第六
14、章 质量控制Chapter 7 Contract Manufacturing and Analysis 第七章 外包生产和样品分析Chapter 8 Complaints and Product Recall 第八章 投诉和成品召回Chapter 9 Self Inspection 第九章 自检,12,EU Guidelines to GMP欧洲GMP指南,Annex 1 Manufacture of Sterile Medicinal Products 附录一 无菌药品的生产Annex 2 Manufacture of Biological Medicinal Products for Hu
15、man Use 附录二 人用生物药品的生产Annex 3 Manufacture of Radiopharmaceuticals 附录三 放射药品的生产Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products 附录四 非免疫动物药品的生产 Annex 5 Manufacture of Immunological Veterinary Medicinal Products 附录五 免疫动物药品的生产,13,EU Guidelines to GMP欧洲GMP指南,
