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PIC/S GUIDANCE PIC/S指南 GOOD PRACTICES FOR DATA MANAGEMENT ANDINTEGRITY IN REGULATED 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 commercialpurposes. Reproduction for internal use is authorised, providedthat the source is acknowledged. Editor: PIC/S Secretariat
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
5.3 Risk management approach to data governance
5.4 Data criticality
5.5 Data risk
5.6 Data governance system review
6. Organisational influences on successful data 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
6.6 Resource allocation
6.7 Dealing with data integrity issues found internally
7. General data integrity principles and enablers
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
8.4 Expectations for the generation, distribution and control of records
8.5 Use and control of records within production areas
8.6 Filling out records
8.7 Making corrections on records
8.8 Verification of records
8.9 Maintaining records
8.10 Direct print-outs from electronic systems
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
9.1 Structure of QMS and control of computerised systems
9.2 Qualification and validation of computerised systems
9.3 System security for computerised systems
9.4 Audit trails for computerised systems
9.5 Data capture/entry for computerised systems
9.6 Review of data within computerised systems
9.7 Storage, archival and disposal of electronic data
10. Data integrity considerations for outsourced activities
10.1 General supply chain considerations
10.2 Routine document verification
10.3 Strategies for assessing data integrity in the supply chain
11. Regulatory actions in response to data integrity findings
11.1 Deficiency references
11.2 Classification of deficiencies
12. Remediation of data integrity failures
12.1 Responding to significant data integrity issues
12.2 Indicators of improvement
13. Definitions
14. Revision history
1 DOCUMENT HISTORY 文件历史 Draft 1 of PI 041-1 presented to the PIC/S Committee at its meeting in Manchester | | 曼彻斯特会议期间PI 041-1草案提交给PIC/S委员会 | | Consultation of PIC/S Participating Authorities on publication of the Good Practices as a draft and implementation on a trial basis | | 公布PIC/S草案征求参与药监机构意见及试行 | | Minor edits to Draft 1 | | 第1版本草案轻微修订 | | Publication of Draft 2 on the PIC/S website | | 第2版本草案在PIC/S网站上公布 | | 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 | | 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 | | PI 041-1被委员会采纳 | | Entry into force of PI 041-1 | | PI 041-1生效 | |
2 INTRODUCTION 引言2.1 PIC/S ParticipatingAuthorities regularly undertake inspections of manufacturers and distributorsof API and medicinal products in order to determine the level of compliancewith GMP/GDP principles. These inspections are commonly performed on-site howevermay be performed through the remote or off-site evaluation of documentaryevidence, in which case the limitations of remote review of data should beconsidered. 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 theseinspection processes is determined by the veracity of the evidence provided tothe inspector and ultimately the integrity of the underlying data. It iscritical to the inspection process that inspectors can determine and fully relyon 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检查过程来说非常关键。 2.3 Good data managementpractices influence the integrity of all data generated and recorded by amanufacturer and these practices should ensure that data is accurate, completeand reliable. While the main focus of this document is in relation to dataintegrity expectations, the principles herein should also be considered in thewider 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 definedas “the extent to which all data are complete, consistent and accurate,throughout the data lifecycle” [1]1 and isfundamental in a pharmaceutical quality system which ensures that medicines areof the required quality. Poor data integrity practices and vulnerabilitiesundermine the quality of records and evidence, and may ultimately undermine thequality of medicinal products. 数据完整性定义为“所有数据在整个生命周期均完整、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 toall elements of the Quality Management System and the principles herein applyequally 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 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 potentialvulnerabilities and take steps to design and implement good data governancepractices 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。
[1] MHRA GMP Data Integrity Definitions and Guidance forIndustry March 2015 MHRA GMP数据完整性定义和行业指南,2015年3月
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