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.docx

1、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 GUIDANCEPIC/S指南PIC/S：国际药品监查合作计划GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATEDGMP/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 20162016年8月Reproduction prohibited for commercial purposes.Reproductio

2、n for internal use is authorised, provided that the source is acknowledged.TABLE OF CONTENTS目录1. Document history文件历史2. Introduction引言3. Purpose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 governanc

3、e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 Man

4、agement 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-based

5、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/recordsQMS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

6、records产生、分发和控制记录的要求8.5 Use 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 Limita

7、tions 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. Specific data integrity considerations for computerised systems计算机化系统特定数据完整性考虑9.1 Structure of QMS and control of computerised systemsQMS结果和计算机化系统的控制9.2 Qualification and valida

8、tion of computerised systems计算机化系统的确认和验证9.3 System security for computerised systems计算机化系统的系统安全9.4 Audit trails for computerised systems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

9、 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 assessing data integrity in the supply chain供应链中数据完整性评估策略11. Regulatory actions in respons

10、e 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 histor

11、y版本历史1 DOCUMENT HISTORY文件历史Draft 1 of PI 041-1 presented to the PIC/S Committee at its meeting in Manchester4-5 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 basis18 July

12、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 11 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 website10 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 Authorities10 August 20

13、16 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 AuthoritiesPIC/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 ofPI 041-1DatePI 041-1被委员会采纳Entry into force ofPI 041-1DatePI 041-1生效2 INTRODUCTION引言2.1 PIC/S Participating Authoritie

14、s regularly undertake inspections of manufacturers and distributors of API and medicinal products in order to determine the level of compliance with GMP/GDP principles. These inspections are commonly performed on-site however may be performed through the remote or off-site evaluation of documentary

15、evidence, in which case 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 these inspection processes is determined by the veracity of the evidence provided to the in

16、spector 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 presented to them.这些检查流程的有效性是由提供给检查员的证据的真实性所决定的，并最终决定于数据背后的完整性。检查员可以确定并完全依赖呈交给他们的证据和记录的完整性和准确性对于

17、检查过程来说非常关键。2.3 Good data management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable. While the main focus of this document is in relation to data integrity expectations, the principl

18、es herein should also be considered in the wider context of good data management.优良数据管理规范影响生产商所产生和记录的所有数据，这些做法应能保证数据是准确的、完整的和可靠的。尽管此文件主要关注的是数据完整性要求，在更广的优良数据管理环境下也应考虑此指南所述原则。2.4 Data Integrity is defined as “the extent to which all data are complete, consistent and accurate, throughout the data lifec

19、ycle”11 and is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. Poor data integrity practices and vulnerabilities undermine the quality of records and evidence, and may ultimately undermine the quality of medicinal products.数据完整性定义为“所有数据在整个生命周期

20、均完整、一致和准确的程度”，它在药物质量体系中是基本的要求，它确保药品具备所需的质量。不良的数据完整性做法和弱点会削弱记录和证据的质量，并最终可能破坏药品质量。2.5 Data integrity applies to all elements of the Quality Management System and the principles herein apply equally to data generated by electronic and paper-based systems.数据完整性适用于质量管理体系的所有要素，此中原则等同适用于电子和纸质系统产生的数据。2.6 Th

21、e responsibility for good practices regarding data management and integrity lies with the manufacturer or distributor undergoing inspection. They have full responsibility and a duty to assess their data management systems for potential vulnerabilities and take steps to design and implement good data

22、 governance practices to ensure data integrity is maintained.数据管理和完整性优良规范的职责由接受检查的生产商或销售商承担。他们负有全部职责和义务来评估其数据管理体系，发现潜在弱点，设计和实施优良数据管理规范来确保数据完整性得到维护。3 PURPOSE目的3.1 This document was written with the aim of:本文件编制的目的是：3.1.1 Providing guidance for inspectorates in the interpretation of GMP/GDP requiremen

23、ts in relation to data integrity and the conduct of inspections.为检查员提供与数据完整性相关的GMP/GDP要求诠释及实施检查相关指南。3.1.2 Providing consolidated, illustrative guidance on risk-based control strategies which enable the existing requirements for data integrity and reliability as described in PIC/S Guides for GMP2and

24、GDP3to be implemented in the context of modern industry practices and globalised supply chains.对基于风险的控制策略提供详细解说的整合指南，促使GMP和GDP的PIC/S指南中所述的现有数据完整性要求和可靠性在现代化工业做法和全球化供应链的环境下得到实施。3.1.3 Facilitating the effective implementation of data integrity elements into the routine planning and conduct of GMP/GDP i

25、nspections; to provide a tool to harmonise GMP/GDP inspections and to ensure the quality of inspections with regards to data integrity expectations.促进数据完整性要素在日常规划和实施GMP/GDP检查中有效实施，提供一个工具让GMP/GDP检查保持一致，保证数据完整性要求方面的检查质量。3.2 This guidance, together with inspectorate resources such as aide memoire (for

26、future development) should enable the inspector to make an optimal use of the inspection time and an optimal evaluation of data integrity elements during an inspection.本指南与检查团资源，例如备忘录（用于进一步展开）一起让检查员优化使用检查时间，在检查中更好地评估数据完整性要素。3.3 Guidance herein should assist the inspectorate in planning a risk-based

27、inspection relating to data integrity.本指南应协助检查组织规划基于风险的数据完整性相关检查。3.4 This guide is not intended to impose additional regulatory burden upon regulated entities, rather it is intended to provide guidance on the interpretation of existing PIC/S GMP/GDP requirements relating to current industry practice

28、.本指南无意对受法规规范的主体形成强制的法规责任，它意在为目前行业规范相关的已有PIC/S GMP/GDP要求提供诠释。3.5 The principles of data integrity apply equally to both manual and computerized systems and should not place any restraint upon the development or adoption of new concepts or technologies. In accordance with ICH Q10 principles, this guid

29、e should facilitate the adoption of innovative technologies through continual improvement.数据完整性原则等同适用于手动和计算机化系统，不应该对发展和采用新概念或技术形成限制。根据ICH Q10原则，本指南应有助于通过持续改进采纳创新技术。3.6 This version of the guidance is intended to provide a basic overview of key principles regarding data management and integrity. The

30、PIC/S Data Integrity Working Group will periodically update, amend and review this guidance in light of inspectorate feedback, experience in using the guide and any other developments.本版本指南意在为数据管理和完整性核心原则提供基本概貌。PIC/S数据完整性工作组将定期进行更新，根据检查团的反馈、使用本指南的经验以及任何其它发展修订和审核本指南。4 SCOPE范围4.1 The guidance has been

31、 written to apply to both on-site and remote (desktop) inspections of those sites performing manufacturing (GMP) and distribution (GDP) activities. The guide should be considered as a non-exhaustive list of areas to be considered during inspection.本指南适用于现场和远程（桌面）检查那些实施生产（GMP）和销售（GDP）活动的场所。本指南应作为检查期间要考虑领域的未尽清单。4.2 Whilst this document has been written with the above scope, many principles regarding good data management practices described herein have applications for other areas of the regulated pharmaceutical and healthcare industry.