PIC/S 受法规约束的GMP/GDP环境下数据管理和完整

性优良规范（中英文）

PIC/S GUIDANCE

PIC/S指南

PIC/S：国际药品监查合作计划

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED

GMP/GDP ENVIRONMENTS

受法规约束的GMP/GDP环境下数据管理和完整性优良规范

PIC/S August 2016

2016年8月

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TABLE OF CONTENTS 目录 1. Document history 2. Introduction 3. Purpose 4. Scope 5. Data governance system 5.1 What is data governance 5.2 Data governance systems 文件历史 引言 目的 范围 数据管理系统 什么是数据管理 数据管理系统 5.3 Risk management approach to data governance 数据管理的风险管理方法 5.4 Data criticality 5.5 Data risk 5.6 Data governance system review 数据关键度 数据风险 数据管理体系审核 6. Organisational influences on successful data 公司对数据完整性管理成功与否integrity management 6.1 General 6.2 Code of ethics and policies 6.3 Quality culture 6.4 Modernising the Pharmaceutical Quality Management System 6.5 Regular management review of quality metrics 质量尺度的定期管理评审 6.6 Resource allocation 6.7 Dealing with data integrity issues found internally 7. General data integrity principles and enablers 一般数据完整性原则和推进者 8. Specific data integrity considerations for paper-based systems 8.1 Structure of QMS and control of blank forms/templates/records 8.2 Why is the control of records important? 8.3 Generation, distribution and control of template records QMS结构和空白表格/模板/记录的控制 为什么记录的控制如此重要？ 模板式记录的产生、分发和控制 纸质系统特定数据完整性考虑 资源配置 内部发现的数据完整性问题处理 的影响 概述 道德和方针准则 质量文化 药物质量管理体系现代化 TABLE OF CONTENTS 目录 8.4 Expectations for the generation, distribution and control of records 8.5 Use and control of records within production 生产区域内记录的使用和控制 areas 8.6 Filling out records 8.7 Making corrections on records 8.8 Verification of records 8.9 Maintaining records 记录填写 记录更正 记录核查 记录维护 产生、分发和控制记录的要求 8.10 Direct print-outs from electronic systems 从电子系统中直接打印出的记录 8.11 True copies 8.12 Limitations of remote review of summary reports 8.13 Document retention 8.14 Disposal of original records 9. Specific data integrity considerations for computerised systems 文件保存 原始记录的废弃 计算机化系统特定数据完整性考虑 真实备份 远程审核报告摘要的局限性 9.1 Structure of QMS and control of computerised QMS结果和计算机化系统的控制 systems 9.2 Qualification and validation of computerised 计算机化系统的确认和验证 systems 9.3 System security for computerised systems 9.4 Audit trails for computerised systems 计算机化系统的系统安全 计算机化系统的审计追踪 9.5 Data capture/entry for computerised systems 计算机化系统的数据捕获/输入 9.6 Review of data within computerised systems 计算机化系统内的数据审核 9.7 Storage, archival and disposal of electronic 电子数据的存贮、归档和废弃 data 10. Data integrity considerations for outsourced 外包活动的数据完整性考虑 activities 10.1 General supply chain considerations 10.2 Routine document verification 一般供应链考虑 日常文件核查 10.3 Strategies for assessing data integrity in 供应链中数据完整性评估策略 the supply chain