2011 PIC-S 工厂主文件指南.docVIP

? 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 ? ?PIC/S January 2011 Reproduction prohibited for commercial purposes Reproduction for internal use is authorized Provided that the source is acknowledged ? Editor/编著: ?????? PIC/S Secretariat email/邮箱: ??????? info@ 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