PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 1 July 2021 PIC/S GUIDANCE GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS © PIC/S 2021 Reproduction prohibited for commercial purposes. Reproduction for internal use is authori...
4234 PICS 数据完整性 20210701 中英文1.pdf,PIC/S GUIDANCE PI 041-1 Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments 202107 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 1 July
PI041-1 10August2016 翻 译 : 朗 脉 S h a w n H s u 翻 译 仅 作 为 参 考 引 用 时 , 应 使 用 P I C / S 官 网 的 原 文 2/87 TABLEOFCONTENTS 目录 1DOCUMENTHISTORY/文件历史...7 2INTRODUCTION/简介...
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内容提示: PIC/S GUIDANCE PI 041-1 Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments 202107 PICS GMP/GDP 环境下数据完整性指南 20210701 译文仅供参考 翻译:JULIA 页 1 / 84 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 1 ...
1 DOCUMENT HISTORY 文件历史 Adoption by Committee of PI 041-1 PI 041-1被委员会采纳 [Date] Entry into force of PI 041-1 PI 041-1生效 [Date] 译者注:相对于2016年8月份的02版,此处省略了前两版征求意见稿的修订历史。 2 INTRODUCTION 介绍 2.1 PIC/S Participating Authorities regular...
响应12.2Indicatorsofimprovement改善指标13.Definitions定义14.Revisionhistory版本历史DOCUMENTHISTORY文件历史Draft1ofPI041-1presentedtothePIC/SCommitteeatitsmeetinginManchester4-5July2016曼彻斯特会议期间PI041-1草案提交给PIC/S委员会2016年7月4-5日ConsultationofPIC/SParticipatingAuthoritiesonpublicationoftheGood...
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PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) 制药检查合作组织 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATEDGMP/GDP ENVIRONMENTS GMP/GDP 环境下数据管理和完整性良好规范 DRAFT PIC/S GUIDANCE (draft 2 ) 指南(草案第二稿) PI041-1 10 August ...
Revision history 版本历史 PIC/S GUIDANCE/GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (draft) Page 4 / 56 PIC/S 在受法规约束的 GMP/GDP 环境下数据管理和完整性优良规范(草案) 翻译:Julia 1 DOCUMENT HISTORY 文件历史 Draft 1 of PI 041-1 presented to the ...