推荐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