AIPIC：基于风险的数据完整性管理实践指南（60页）.pdf

1、APIC/Practical risk-based guide for managing data integrity Version 1,March 2019 APIC 基于风险的数据完整性管理实践指南 第 1 版 201903 翻译 JULIA 页 1/60 ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE Practical risk-based guide for managing data integrity 基于风险的数据完整性管理实践指南基于风险的数据完整性管理实践指南 Version 1,March 2019 第第 1 版版 2019 年年

2、 3 月月 APIC/Practical risk-based guide for managing data integrity Version 1,March 2019 APIC 基于风险的数据完整性管理实践指南 第 1 版 201903 翻译 JULIA 页 2/60 PREAMBLE 前言前言 This original version of this guidance document has been compiled by a subdivision of the APIC Data Integrity Task Force on behalf of the Active Pha

3、rmaceutical Ingredient Committee(APIC)of CEFIC.本指南初版由 APIC 数据完整性工作组代表 CEFIC 的 APIC 编纂。The Task Force members are:Charles Gibbons,AbbVie,Ireland Danny De Scheemaecker,Janssen Pharmaceutica NV Rob De Proost,Janssen Pharmaceutica NV Dieter Vanderlinden,S.A.Ajinomoto Omnichem N.V.Andr van der Biezen,Asp

4、en Oss B.V.Sebastian Fuchs,Tereos Daniel Davies,Lonza AG Fraser Strachan,DSM Bjorn Van Krevelen,Janssen Pharmaceutica NV Alessandro Fava,F.I.S.(Fabbrica Italiana Sintetici)SpA Alexandra Silva,Hovione FarmaCiencia SA Nicola Martone,DSM Sinochem Pharmaceuticals Ulrich-Andreas Opitz,Merck KGaA Dominiqu

5、e Rasewsky,Merck KGaA With support and review from:Pieter van der Hoeven,APIC,Belgium Francois Vandeweyer,Janssen Pharmaceutica NV Annick Bonneure,APIC,Belgium The APIC Quality Working Group APIC/Practical risk-based guide for managing data integrity Version 1,March 2019 APIC 基于风险的数据完整性管理实践指南 第 1 版

6、201903 翻译 JULIA 页 3/60 Contents 目录 1.General Section通用部分通用部分 1.1 Introduction 简介 1.2 Objectives and Scope 目的与范围 1.3 Definitions and abbreviations 定义与缩写 1.4 Overall Data Integrity Approach 数据完整性方法概述 2 Business Processing Mapping 业务流程分析业务流程分析 3 Data and System Identification 数据与系统识别数据与系统识别 4 Data and