欧盟GMP中英对照版1-9章T-Make.doc

欧盟GMP 欧盟人与兽用药品生产质量管理规范汇编 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 欧盟药事法规第4卷 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP指南 第 0部分-简介(2008) 文件历史 日期 发行本指南第一版,其包括一个无菌药品制造附录。 1989 发行第二版指南;贯彻关于人用药品与兽用药品GMP基本原则与指南的1991年六月13日91/356号与1991年七月23日91/412号委员会指令。第二版包含增加的12个附录。 1992年一月 更新了所参照的法规。同时,该指南根据欧洲委员会对网络要求,加入了几个附录。 2004年八月 重新构建 GMP指南,贯彻第2004/27/EC与 2004/28/EC号指令,组成人用与兽用药品的第一部分以及作为起始物料的原料药为第二部分。现行指南包括 17个附录,先前第18附录被取代。 2005年十月 作为GMP的第20附录贯彻ICH-Q9指南。 2008年三月 欧盟GMP官方网站： http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htmThe pharmaceutical industry of the European Union maintains high standards of quality assurance in the development, manufacture and control of medicinal products. A system of marketing authorisations ensures that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality and efficacy. A system of manufacturing authorisations ensures that all products authorised on the European market are manufactured only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Manufacturing authorisations are required by all pharmaceutical manufacturers in the European Community whether the products are sold within or outside of the Community. 在药品研发,制造与质量控制方面,欧盟制药工业界保持着高质量保证标准。药品上市许可体系确保官方按现行标准对所有药品的安全性 ,质量和有效性进行评价。药品制造许可体系确保只有经批准的药品制造企业,才能制造在欧洲市场销售的药品,其全部活动要接受官方定期检查。不管所制造产品是在欧盟销售 ,还是在欧盟以外的国家销售,欧盟所有药品制造企业都须经有制造许可。 Two directives laying down principles and guidelines of good manufacturing practice (GMP) for medicinal products were adopted by the Commission. Directive 2003/94/EC applies to medicinal products for human use and Directive 91/412/EEC for veterinary use. Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice which will be used in assessing applications for manufacturing authorisations and as a basis