WHO现场主文件编写指南

© World Health Organization

WHO Technical Report Series, No.961, 2011

附件14

Annex 14

WHO现场主文件编写指南1

WHO guidelines for drafting a site master file1

1. 介绍Introduction

2. 目的Purpose

3. 范围Scope

4. 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 file

1. 介绍Introduction

1.1 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 pharmaceuticalmanufacturer and should contain specific information about the qualitymanagement policies and activities of the site, the production and/or qualitycontrol of pharmaceutical manufacturing operations carried out at the namedsite and any closely integrated operations at adjacent and nearby buildings.If only part of a pharmaceutical operation is carried out on the site, an SMFneed only describe those operations, e.g. analysis, packaging, etc.

1.2 当提交给监管机构时，现场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 provideclear information onthe manufacturer’s good manufacturing practices(GMP)-related activities that can be useful in general supervision and in theefficient planning and undertaking of GMP 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25～30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 25–30 pages plus appendices. Simple plans, outline drawings orschematic layouts are preferred instead of narratives. The SMF, includingappendices, 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 the 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 individual 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 medicinalproducts in the preparation of an SMF that is useful to the regulatoryauthority in planning and conducting 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 andor national regulatory requirements to establish whether it is mandatory for manufacturers 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 medicinal 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).