content of site master file最新修订版.docVIP

Content of Site Master File 现场主文件清单 General Information on the Manufacturer 企业总体情况 Contact information on the manufacturer 企业联系信息 Name and official address of the manufacturer; 企业名称、注册地址； Names and street addresses of the site, buildings and production units located on the site; 企业生产工厂以及工厂内建筑及生产车间名称和地址； Contact information of the manufacturer including 24 hrs telephone number of the contact personnel in the case of product defects or recalls; 企业联系方式（包括出现产品缺陷或召回事件时24小时联系人电话）; Identification number of the site as e.g. GPS details, D-U-N-S (Data Universal Numbering System) Number (a unique identification number provided by Dun Bradstreet) of the site or any other geographic location system. 现场识别号码，例如GPS详细情况，D-U-N-S号码（数据通用编号系统）（一个由Dun Bradstreet提供的独特识别号码）或者任何其他地理定位系统。 Authorised pharmaceutical manufacturing activities of the site. 药品生产许可范围 Copy of the valid manufacturing authorization issued by the relevant Competent Authority in Appendix 1; or when applicable, reference to the EudraGMP database. If the Competent Authority does not issue manufacturing authorizations, this should be stated; 附件1中提供相关监管机构签发的有效生产许可文本复印件，必要时，可参考EudraGMP数据库。如遇监管机构不签发生产许可情况，应予以说明。 Brief description of manufacture, import, export, distribution and other activities as authorised by the relevant Competent Authorities including foreign authorities with authorized dosage forms/activities, respectively; where not covered by the manufacturing authorization; 简要描述由相关监管机构许可的生产、进口、出口、分销和其他活动，包括许可文件中没有提及的国外机构许可的剂型/生产活动等; Type of products currently manufactured on-site (list in Appendix 2) where not covered by Appendix 1 or the EudraGMP database; 在附件2中列出附录1或EudraGMP数据库中没有提及的工厂目前生产的产品类型; List of GMP inspections of the site within the last 5 years; including dates and name/country of the Competent Authorities having performed the inspection. A copy of current GMP certificate (Appendix 3) or reference to the EudraGMP database should be included, if available. 近5年工厂接受GMP检查情况，包括检查时间和实施检查的监管机构名称及国家。如果有，请在附件3中