WHO现场主文件编写指南.docx

1、WHO现场主文件编写指南附件14Annex 14WHO现场主文件编写指南1WHO guidelines for drafting a site master file11. 介绍Introduction2. 目的Purpose3. 范围Scope4. 现场主文件的内容Content of site master file附件Appendix现场主文件的内容Content of a site master file1. 介绍Introduction1.1 现场主文件是由药品制药商编写的，应当包含下列具体的信息：生产厂区的质量管理方针及活动、在指定的生产厂区实行的对药品生产操作的生产和/或质量控制

2、以及在与其相邻的建筑物内所进行的任何紧密的完整的操作。如果只有一部分药品生产操作在此厂区内进行，那么在现场主文件中只需要描述这些操作，例如分析、包装等。The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pha

3、rmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, an SMF need only describe those operations, e.g. analysis, packaging, etc.1.2 当提交给监管机构时，现场

4、主文件中应当包含对常规监督、有效计划及进行GMP检查有用的、关于制造商与GMP相关的活动的清晰信息。When submitted to a regulatory authority, the SMF should provide clear information on the manufacturers good manufacturing practices (GMP)-related activities that can be useful in general supervision and in the efficient planning and undertaking of G

5、MP inspections.1.3 现场主文件中应当包含足够的信息，但加上附件尽量不要超过2530页。用简单的计划、轮廓图或示意图来替代叙述性的文字是更可取的。当用A4纸张打印出时，现场主文件及其附件应当是可读的。An SMF should contain adequate information but, as far as possible, not exceed 2530 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred instead of narrativ

6、es. The SMF, including appendices, should be readable when printed on A4 paper sheets.1.4 现场主文件应是制造商质量管理体系文件的一部分，且应持续更新。现场主文件应有版本号、生效期和必须对其进行审核的日期。应当定期对现场主文件进行回顾以保证其包含了最新的信息和代表了当前所进行的活动。每个附件可以有单独的生效期，以便进行独立的更新。The SMF should be a part of documentation belonging to the quality management system of th

7、e manufacturer and kept updated accordingly. The SMF should have an edition number, the date it becomes effective and the date by which it has to be reviewed. It should be subject to regular review to ensure that it is up to date and representative of current activities. Each annex can have an indiv

8、idual effective date, allowing for independent updating.2. 目的Purpose这些注释的目的是：在药品制造商编写现场主文件时提供指导，现场主文件在监管机构计划和进行GMP检查时有用的。The aim of these explanatory notes is to guide the manufacturer of medicinal products in the preparation of an SMF that is useful to the regulatory authority in planning and condu

9、cting GMP inspections.3. 范围Scope这些注释适用于现场主文件的编写及内容的确定。制造商应参照区域性的和/或国家监管要求来确定编写现场主文件是否是强制性的要求。These explanatory notes apply to the preparation and content of the SMF. Manufacturers should refer to regional and or national regulatory requirements to establish whether it is mandatory for manufacturers

10、of medicinal products to prepare an SMF.这些注释适用于各种制造操作，例如各种药品的生产、包装和贴签、检测、重新贴签和重新包装。本指南中的概述也可用于指导血液和组织制品和原料药（API）制造商编写现场主文件或相应的文件。These explanatory notes apply for all kinds of manufacturing operations such as production, packaging and labelling, testing, relabelling and repackaging of all types of m

11、edicinal products. The outlines of this guide could also be used in the preparation of an SMF or corresponding document by blood and tissue establishments and manufacturers of active pharmaceutical ingredients (APIs).4. 现场主文件的内容Content of site master file格式参照附件。Refer to the Appendix for the format t

12、o be used.附件Appendix场主文件的内容Content of a site master file1. 制造商基本信息General information on the manufacturer 1.1制造商联系信息Contact information on the manufacturer - 制造商名称及官方地址；name and official address of the manufacturer;- 生产厂地名称及街道地址，在生产厂地内的建筑物和生产单元；names and street addresses of the site, buildings and p

13、roduction units located on the site;- 制造商联系信息，包括在产品缺陷或召回时，相关联系人的24小时联系号码；以及contact information of the manufacturer including 24-hour telephone number of the contact personnel in the case of product defects or recalls; and- 生产厂地的识别码，例如全球地位系统（GPS）详细信息、生产厂地或其它地理系统D-U-N-S（数据通用编号系统）编号（由Dun & Bradstreet提供

14、的识别码）。identification number of the site as e.g. global positioning system (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 geographical location system.1.2生产厂地被授权的药品生产活动Authorized pharmaceutical man

15、ufacturing activities of the site- 主管部门颁发的有效的生产许可证的复印件作为附件一；或者当适用时，索引到EudraGMP数据库。如果主管部门不颁发生产许可证，应当进行声明。copy of the valid manufacturing authorization issued by the relevant competent authority in Annex 1; or when applicable, reference to the EudraGMP database. If the competent authority does not iss

16、ue manufacturing authorizations, this should be stated;- 如果没有涵盖在生产许可证范围时，简述由相关主管部门，包括国外监管机构授权的制造、进口、出口、分发和其他活动，授权的剂型/活动，应根据许可的剂型/活动分别叙述；brief description of manufacture, import, export, distribution and other activities as authorized by the relevant competent authorities including foreign authorities with authorized dosage forms/activities, respectively; where not covered by the manufa