欧盟GMP附录1中英文译稿B版.doc

欧盟《GMP》附录1 无菌药品生产 -  PAGE 26 - EUROPEAN COMMISSION（欧盟委员会） ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL（企业和工业常务委员会） Consumer goods 食品 Pharmaceuticals 药品 Brussels, 14 February 2008 布鲁塞尔 2008.2.14 EudraLex The Rules Governing Medicinal Products in the European Union 欧盟医药产品通则 Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use 欧盟药事法规第4卷 人用药品及兽药生产质量管理规范 Annex 1 Manufacture of Sterile Medicinal Products 附录1 无菌药品的生产 Document HistoryPrevious version dated 30 May 2003, in operation since 上一版本2003.5.30发布September 2003 自2003年9月生效Revision to align classification table of clean rooms, to include guidance on media simultations, bioburden monitoring and capping of freeze-dried vials 修订了洁净间级别表，培养基模拟试验、生物负荷监测和冻干小瓶??盖的指南（调整洁净区分类表，包括医疗器械、放射性产品和冻干制剂）November 2005 to December 2007 2005年11月至2007年12月Date for coming into operation and superseding 生效并替代前版（实施日期）01 March 2009 2009年3月1日 1 Note: Provisions on capping of freeze-dried vials should be implemented by 01 March 2010. 注意：冻干制剂轧盖的条款自2010年3月1日开始实施 Principle 原则 The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance is particularly important, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test. 为降低微生物、微粒和热源污染的风险，无菌药品的生产应有各种特殊的要求。很大程度上取决于生产人员的技能、接受的培训及工作态度。质量保证极为重要，并且无菌药品的生产必须严格按照精心制定并经验证的方法及规程进行。产品的无菌或其他质量特性不能仅依赖于任何形式的最终操作或成品检验。 Note:This guidance does not lay down detailed methods for determining the microbiological and particulate cleanliness of air, surfaces etc. Reference should be made to other documents such as the Standards. 注：本指南没有对微粒、浮游菌和表面微生物等测试方法详细进行阐述，可参考其他欧洲