PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION COOPERATION SCHEME
药品检查协定和药品检查合作计划组织
PE 0084
1 Annex
1 January 2011
PE 0084
附件一
2011年1月1日
EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE
制药工厂现场主文件编写说明
Editor/编著:
PIC/S Secretariat
email/邮箱:
editor does not contain ainfo@
web site/网站:
TABLE OF CONTENTS
目录
1 Document History/文件历史...................................................................................2
2 Introduction/简介....................................................................................................2
3 Purpose/目的.........................................................................................................2
4 Scope/范围............................................................................................................3
5 Content of Site Master File/现场主文件内容..........................................................3
6 Revision History/修订历史.....................................................................................3
1 DOCUMENT HISTORY 文件历史
2 INTRODUCTION 简介
Adoption by the PIC Committee of Officials of PH 4/93
PIC委员会正式采用PH4/93
22-23 April 1993
1993年4月22-23
Entry into force of PH 4/93
PH 4/93 生效
April 1993
1993年3月
Entry into force of PE 0081
PE 0081生效
1 November 2002
2002年11月1日
2.1    The Site Master File 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 pharmaceutical 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, a Site Master File need only describe those operations, e.g. analysis, packaging, etc.
现场主文件是由制药厂家编写，并包含以下信息：质量管理方针及现场活动、在对在指定现场进行生产或/和对在指定现场的制药生产操作进行的质量控制以及在临近及附近建筑内进行的一体化操作。如果仅有一部份制药操作在该现场进行，那么SMF仅需描叙该类操作即可，如：分析、包装、等。
2.2    When submitted to a regulatory authority, the Site Master File should provide clear information on the manufacturer’s GMP related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections.
提交至监管机构时，ＳＭＦ需提供明确信息，说明厂家进行的有助于一般监管和ＧＭＰ审查
有效计划和应对的相关ＧＭＰ活动
2.3    A Site Master File 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 narratives. The Site Master File, including appendices, should be readable when printed on A4 paper sheets.
ＳＭＦ应包含足够的信息，但是加上附件不得超过２５３０页。相较于详述，简单性计划、简略的原理图布局图为首选。ＳＭＦ，包括附件，用Ａ４纸打印出来应当可读。
2.4    The Site Master File should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. The Site Master File 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 Appendix can have an individual effective date, allowing for independent updating.
ＳＭＦ厂家质量管理系统文件的一部分，应进行相应更新。ＳＭＦ应当有一个版本号、生效日期以及需进行审核的日期。应对ＳＭＦ进行定期审核以保证其为最新版本并体现最新行动。每个附件可有单独的生效日期，允许单独对附件进行更新。
3.    PURPOSE目的
The aim of these Explanatory Notes is to guide the manufacturer of medicinal products in the preparation of a Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections.
本说明的目的是指导医药生产厂家进行ＳＭＦ的编写。ＳＭＦ在监管机构进行ＧＭＰ审查计划和执行ＧＭＰ审查中是有用的。
4. SCOPE 适用范围
These Explanatory Notes apply to the preparation and content of the Site Master File. Manufacturers should refer to regional / national regulatory requirements to establish wheth
er it is mandatory for manufacturers of medicinal products to prepare a Site Master File.
本说明使用与ＳＭＦ的编写及内容。厂家应参考地区／国家法规要求以确定是否强制要求医药用品厂家编写ＳＭＦ。
These Explanatory Notes apply for all kind 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 a Site Master File or corresponding document by Blood and Tissue Establishments and manufacturers of Active Pharmaceutical Ingredients.
本说明适用于下述此类生产操作：所有类型医药产品的生产、包装和贴标、检验、再贴标和再包装。本指南的大纲也可以用于编写ＳＭＦ或ＡＰＩ血液和组织制造机构以及生产厂家相关文件的编写。

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