CO¬OPERATION SCHEME

木头1985

CO¬OPERATION SCHEME
药品检查协定和药品检查合作计划组织

PE 008¬4
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












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
Adoption by the PIC Committee of Officials of PH 4/93
PIC委员会正式采用PH4/93