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受法规约束的GMP和GDP环境下数据管理和完整性优良规范(中英文)

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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

Reproduction prohibited for commercial purpos.

Reproduction for internal u is authorid, provided that the source is acknowledged.

TABLE OF CONTENTS 目录
1. Document history	文件历史
2. Introduction	引言
3. Purpo	目的
4. Scope	范围
5. Data governance system	数据管理系统
5.1 What is data governance	什么是数据管理
5.2 Data governance systems	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	数据关键度
5.5 Data risk	数据风险
5.6 Data governance system review	数据管理体系审核
6. Organisational influences on successful data integrity management	公司对数据完整性管理成功与否的影响
6.1 General	概述
6.2 Code of ethics and policies	道德和方针准则
6.3 Quality culture	质量文化
6.4 Modernising the Pharmaceutical Quality Management System	药物质量管理体系现代化
6.5 Regular management review of quality metrics	质量尺度的定期管理评审
6.6 Resource allocation	资源配置
6.7 Dealing with data integrity issues found internally	内部发现的数据完整性问题处理

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-bad systems	纸质系统特定数据完整性考虑
8.1 Structure of QMS and control of blank forms/templates/records	QMS结构和空白表格/模板/记录的控制
8.2 Why is the control of records important?	为什么记录的控制如此重要？
8.3 Generation, distribution and control of template records	模板式记录的产生、分发和控制
8.4 Expectations for the generation, distribution and control of records	产生、分发和控制记录的要求
8.5 U and control of records within production areas	生产区域内记录的使用和控制
8.6 Filling out records	记录填写
8.7 Making corrections on records	记录更正
8.8 Verification of records	记录核查
8.9 Maintaining records	记录维护
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	真实备份
8.12 Limitations of remote review of summary reports	远程审核报告摘要的局限性
8.13 Document retention	文件保存
8.14 Disposal of original records	原始记录的废弃
9. Sp赞美的词 ecific data integrity considerations for computerid systems	计算机化系统特定数据完整性考虑
9.1 Structure of QMS and control of computerid systems	QMS结果和计算机化系统的控制
9.2 Qualification and validation of computerid systems	计算机化系统的确认和验证
9.3 System curity for computerid systems	计算机化系统的系统安全

9.4 Audit trails for computerid systems	计算机化系统的审计追踪
9.5 Data capture/entry for computerid systems	计算机化系统的数据捕获/输入
9.6 Review of data within computerid systems	计算机化系统内的数据审核
9.7 Storage, archival and disposal of electronic data	电子数据的存贮、归档和废弃
10. Data integrity considerations for outsourced activities	外包活动的数据完整性考虑
10.1 General supply chain considerations	一般供应链考虑
10.2 Routine document verification	日常文件核查
10.3 Strategies for asssing data integrity in the supply chain	供应链中数据完整性评估策略
11. Regulatory actions in respon to data integrity findings	数据完整性缺陷引发的法规行动
11.1 Deficiency references	缺陷参考
11.2 Classification of deficiencies	缺陷分类
12. Remediation of data integrity failures	数据完整性失败时的弥补方法
12.1 Responding to significant data integrity issues	对重大数据完整性问题响应
12.2 Indicators of improvement	改善指标
13. Definitions	定义
14. Revision history	版本历史

1 DOCUMENT HISTORY 文件历史

Draft 1 of PI 041-1 p上海本科 rented to the PIC/S Committee at its meeting in Manchester	4-5 July 2016
曼彻斯特会议期间PI 041-1草案提交给PIC/S委员会	2016年7月4-5日
Consultation of PIC/S Participating Authorities on publication of the Good Practices as a draft and implementation on a trial basis	18 July – 31 July 2016
公布PIC/S草案征求参与药监机构意见及试行	2016年7月18日—31日
Minor edits to Draft 1	1 – 9 August 2016
第1版本草案轻微修订	2016年8月1-9日
Publication of Draft 2 on the PIC/S website	10 August 2016
第2版本草案在PIC/S网站上公布	2016年8月10日
Implementation of the draft on a trial basis and comment period for PIC/S Participating Authorities	10 August 2016 – 28 February 2017
试验实施和征求PIC/S参与药监机构意见阶段	2016年8月10日- 2017年2月28日
Review of comments by PIC/S Participating Authorities	…
PIC/S参与药监机构审核所收到的意见
Finalisation of draft	…
草稿定稿
Adoption by Committee of PI 041-1	[Date]
PI 041-1被委员会采纳
Entry into force of PI 041-1	[Date]
PI 041-1生效

2 INTRODUCTION 引言

2.1 PIC/S Participating Authorities regularly undertake inspections of manufacturers and distributors of API and medicinal products in order to determine the level of compliance with GMP/GDP principles. The inspections are commonly performed on-site however may be performed through the remote or off-site evaluation of documentary evidence, in which ca the limitations of remote review of data should be considered.

PIC/S参与药监机构定期对原料药和制剂生产商和销售商进行检查，以确定其GMP/GDP符合性水平。这些检查通常是在现场实施，但也可以通过远程或离厂文件证据评估进行，这时要考虑远程数据审核的局限性。

2.2 The effectiveness of the inspection process is determined by the veracity of the evidence provided to the inspector and ultimately the integrity of the underlying data. It is critical to the inspection process that inspectors can determine and fully rely on the accuracy and completeness of evidence and records prented to them.

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