翻译:JULIA 来自:JUIA法规翻译 国际药品认证合作组织(PIC/S)于 7 月 1 日发布并生效了《受监管GMP/GDP环境下数据管理和完整性优良规范》定稿指南。 该指南最初于 2016 年引入,于 2018 年发布修订版草案。 PIC/S PI 041-1 GOOD PRACTICESFORDATAMANAGEMENT ANDINTEGRITYINREGULATED GMP/GDPENVIRONMENTS 受监管GMP...
翻译:JULIA 来自:JUIA法规翻译 国际药品认证合作组织(PIC/S)于 7 月 1 日发布并生效了《受监管GMP/GDP环境下数据管理和完整性优良规范》定稿指南。 该指南最初于 2016 年引入,于 2018 年发布修订版草案。 PIC/S PI 041-1 GOOD PRACTICESFORDAT...
PIC/S GUIDANCE/GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (draft) Page 1 / 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 PIC/S GUIDANCE PIC/S 指南 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED...
2.6 The responsibility forgood practices regarding data management and integrity lies with themanufacturer or distributor undergoing inspection. They have fullresponsibility and a duty to assess their data management systems for potentialvulnerabilit...
【From - Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments20210701 治理(数据可靠性)目的 1.通过在企业中建立数据治理体系,来向PIC/S检查员证明其所检查记录与数据的数据可靠性 图3. FDA Data Integrity 原则,引用自https://iternity.com/en/ensuring-data-integrity-in-the...
该委员会由GM(D)P协调分委员会通知,要求其将来在PIC/S建立等同于EU GMP附录16(由质量授权人QP认证和批放行)的某些最低要求; · The 6-month trial implementation period for the draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1 (Dr...
PIC / S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN Table of Contents
lPIC/SPE 009 Guide to Good ManufacturingPractice for Medicinal Products, Annexes including PIC/S Annex 20 Quality RiskManagement lPIC/SPE 009药品优良生产规范指南,附录包括PIC/S附录20质量风险管理 lPIC/SPI 043 Aide-Memoire Cross-Contaminationin Shared facilities ...
The developer,Leonardo Custodio, has not provided details about its privacy practices and handling of data to Apple. For more information, see thedeveloper’s privacy policy. No Details Provided The developer will be required to provide privacy details when they submit their next app update. ...
PIC/S最近发布了两份文件,旨在为其成员之间的远程和混合检查的规划、实施和跟踪创建一个统一的方法。 The documents also highlight important factors for assessing whether certain high-risk facilities are unsuitable for remote evaluations. 这些文件还强调了评估某些高风险设施是否不适合进行远程评估的重要因素。