GMP1 F EMEA The European Medicines Agency F

与注册/GMP相关的机构-1 F EMEA ：The European Medicines Agency F 欧洲药品局 F CHMP： Committee for Medicinal Products for Human Use F 人用药品委员会

与注册/GMP相关的机构-2 CVMP：Committee for Medicinal Products for Veterinary Use F 兽药委员会 F HMPC：The Committee on Herbal Medicinal Products was established in 2004 F 植物药品委员会（2004年成立） F 这个委员会对传统植物药提供科学的见解 F

PIC/S 历史 PIC 药品检查条约组织，1970年 由 10个国家创 建：Austria, Denmark, Finland, Iceland, Liechtenstein列支敦士登, Norway, Portugal, Sweden, Switzerland United Kingdom. F Australia 澳大利亚是 1993年PIC药品检查条约 的最后一个成员 F PIC Scheme 药品检查合作计划于1995创建， 同年与条约组织联合办公，成为PIC/S F PIC/S成员因历史原因，不局限于欧洲国家 F

PIC/S现有27个成员国 主要成员 CANADA AUSTRALIA LIECHTENSTEIN BELGIUM NETHERLANDS CANADA NORWAY CZECH REPUBLIC PORTUGAL DENMARK ROMANIA FINLAND SINGAPORE FRANCE SLOVAK REPUBLIC HUNGARY SPAIN ICELAND SWEDEN IRELAND SWITZERLAND (X 2) ITALY UNITED KINGDOM PIC GERMANY AUSTRALIA

Main Features of PIC/S F F F F Commenced operating on 2 Nov. 1995 An informal arrangement between Agencies Networking and confidence building Exchange of information and experience on GMP Development of Quality Systems for Inspectorates Training of inspectors International harmonisation of GMP Convention and Scheme run concurrently (until all PIC members join PIC/S)

二者的区别与联系 PIC Scheme 药品检查计划 PIC 药品检查条约 Scheme（计划/方案/策划） Convention 协定 An informal arrangement 非正式 A formal treaty 正式条约 Has no legal status 无法定地位 Has legal status 法定地位 Between Health authorities 技术权威间 Between countries 国家之间 Exchange of information 信息交流 Mutual recognition of inspections 检查互认

ICH 介绍 F F F ICH= The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) 人用药品注册技术要求国际协调会 80年代，欧共体（现欧盟）提出，先在欧洲试行 统一注册技术要求，获得成功，此后与日本及美 国讨论。 1989年，WHO开始准备 1990年创建ICH

ICH 成员 F F F F European Commission - European Union (EU) 欧盟 European Federation of Pharmaceutical Industries and Associations (EFPIA) 欧洲制药 业联合会 Ministry of Health, Labor and Welfare, Japan (MHLW) 日本卫生、劳动和福利部 Japan Pharmaceutical Manufacturers Association (JPMA) 日本制药企业协会 US Food and Drug Administration (FDA) Pharmaceutical Research and Manufacturers of America (Ph. RMA) 美国药品研究和生产企业协会

ICH 观察员 Observers观察员： F The World Health Organisation (WHO) WHO home page F The European Free Trade Area (EFTA), 欧洲自由贸易区 Swissmedic home page F Canada, 加拿大 Health Products and Food Branch

欧盟GMP的依据 F F F Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products. 2003年 10月8日，委员会指令 2003/94/EC，下发 了人用药品、人用临床研究药品的GMP指南， 替代 1991的版本 ******

欧盟GMP-总则 BASIC REQUIREMENTS 基本要求（通�） 第一章 Quality Management �量管理 第二章 “Product Quality Review - Addition to Chapter 1 to the EU guide to Good Manufacturing Practice” � 品� 量�� 分 析 第三章 Personnel 人� 第四章 Premise and Equipment 厂房和�� 第五章 Documentation 文件和�� 第六章 Production 生� 第七章 Quality Control �量控制 第八章 “On going Stability - Addition to Chapter 6 to the EU Guide to good Manufacturing Practice“ � 定性考察 第九章 Contract Manufacture and Analysis 委托加

欧盟GMP-附录 ANNEXES Annex 1 Manufacture of Sterile Medicinal Products 无菌�品的生� Annex 2 Manufacture of Biological Medicinal Products for Human Use Annex 3 Manufacture of Radio. Pharmaceuticals Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5 Manufacture of Immunological Veterinary Medicinal Products Annex 6 Manufacture of Medicinal Gases Annex 7 Manufacture of Herbal Medicinal Products 植物�生� Annex 8 Sampling of Starting and Packaging Materials Annex 9 Manufacture of Liquids, Creams and Ointments

欧盟GMP-附录续 Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation Annex 11 Computerised Systems Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13 Manufacture of Investigational Medicinal Products Annex 14 Manufacture of Products derived from Human Blood or Human Plasma Annex 15 Qualification and validation (July 2001) 确�和�� Annex 16 Certification by a Qualified person and Batch Release (July 2001) Annex 17 Parametric Release (July 2001) 参数放行 Annex 18 Good manufacturing practice for active pharmaceutical ingredients (July 2001) 注意：附件 16有资格人员资质的确认和批的放行！！

哲理和要素-方法续 F F F Q 7 A: In this Guide the term "should" itentifes recommendations, that when followed, will ensure compliance with CGMP. An alternative approach may be used if such approach satisfies the requirements of the applicable statues. 在原料药Q 7 A引言中提到：本指南用 “should-应当 ” 一词来表示“只要遵循，一定能符合c. GMP要求” 的各种建议，但也可采用其它的方法及手段，只 要它们能满足实际情况的具体要求。 科学态度和科学管理是国际GMP的基本特征

学习国际标准，努力提高水平-续 2 WHO GMP 1992无菌药品附录 17. 24款与2002 版第 10. 6款对水系统的提法完全一致，即：注 射用水的生产、贮存和输送方式，应能防止微 生物生长，例如在 70℃以上或 4℃以下连续循 环。 F 原文：Water should be produced, stored, and distributed in a manner that prevents microbial growth - for example, by constant circulation at 80℃ or not more than 4℃. F

学习国际标准，努力提高水平-续 3 美国药典 28版在 1231章制药用水通则中，技术 要求更为明确： F 水的分配系统有二种方式，循环方式（回流） 或定期冲洗，经验证明，采用循环方式比较容 易保持，…… F Distribution configuration should allow for the continuous flow of water in the piping by means of recirculation or should provide for the periodic flushing of the system. Experience has shown that continuously recirculated systems are easier to maintain. F

网站查阅 法规及技术性指南可从网上查得： F http: //www. fda. gov/ F http: //www. phrma. org/ F http: //www. ich. org/ F http: //www. who. int/ F http//www. emea. eu. int/ F http: //www. picscheme. org/pubs. htm F http: //www. efpia. org/ F

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