SMF编写及内容要求注释-EN+CN.docx

EudraLex The Rules Governing Medicinal Products in the European Union 欧盟药事法规 Volume 4 第4卷 Brussels, 10 December 2009 2009年12月10日，布鲁塞尔 EU Guidelines to 欧盟指南 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use 人用药品及兽药生产质量管理规范 Part III 第III部分 Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master File and content of a Site Master File 药品制造企业现场管理档案（SMF）内容及编写要求注释 翻译：徐禾丰 2009年12月，第1版 Draft agreed by GMP/GDPInspectors Working Groups GMP／GDP检查员工作组批准草案 September 2009 2009年9月 Release for public consultation 发放征求意见 15 December 2009 2009年12月15日 Deadline for comments entr-gmp@ec.europa.eu and ADMGMDP@ema.europa.eu 提交意见给 entr-gmp＠ec.europa.eu与ADMGMDP＠ema.europa.eu的最后期限 31 March 2010 2010年3月31日 Final text agreed by GMP/GDP Inspectors Working Groups GMP／GDP检查员工作组批准最后文本 Adopted by European Commission 欧盟委员会批准 Deadline for coming into operation 实施运行最后期限 The Site Master File concept has been developed by PIC/S and has become a standard expectation of EU authorities. Following a recent revision of the explanatory notes by PIC/S, it has been proposed that the status of the Site Master File is more formally linked to the EU regulatory framework. 现场管理档案的概念由PIC／S开发，并已经成为欧盟当局的一个标准的期望。继最近PIC／S修订解释性说明，已经建议SMF地位更加正式地连接到欧盟药政法规架构中。 It is proposed that a new informational Part III of the EU GMP Guide is created for documents which are not themselves GMP guidelines and have no statutory force but which complement the GMP guidelines and related regulatory procedures such as, in this case, inspections. 建议欧盟GMP指南第III部分编制为新的信息文件，但其本身不是一个GMP指南，也不具有法定效力，但作为GMP指南的一个补充和相关的药政程序，例如，检查。 It is expected that in the future, further documents will be added to the new Part III and that such documents would be included following public consultation. 希望在未来将有更多的文件添加到新的第III部中，并且这些文件也将包括在发放征求意见中。 The document is identical to the content of the Site Master File by PIC/S and is published in parallel. 该文件与PIC／S的现场管理档案内容一致，并平行发布。 Table of contents 目录 1.INTRODUCTION