ISPE GAMP指南：记录和数据可靠性-翻译（3)

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[翻译交流] ISPE GAMP指南：记录和数据可靠性-翻译（1)


[翻译交流] ISPE GAMP指南：记录和数据可靠性-翻译（2)

1.3 Scope范围

Thisguide addresses the integrity of GxP records and data used within the regulatedlife science industries including pharmaceutical, biological, and medicaldevices. The guidance is intended for regulated companies and suppliers ofsystems, products, or services in this area, as wellas a useful reference for regulators.

本指南介绍了包括制药、生物和医疗设备在内的受监管的生命科学行业使用的记录和数据的完整性。该指南旨在为该领域的系统、产品或服务的受监管的公司和供应商提供指导，并为监管机构提供有用的参考。

Applicablelife science regulations and guidance have been takeninto account, and the following publications have been specificallyconsidered:

已考虑到适用的生命科学条例和指导，并特别考虑以下出版物:

•US Code of Federal Regulations (CFRs) covering GCP, GLP, GMP, and medicaldevices

•US 21 CFR Part 11and associated guidance

•Relevant sections of EU GMPs including Chapter 4 and Annex 11

•MHRA GMP Data Integrity Definitions and Guidance for Industry (Revision 1.1,March 2015)

•MHRA GxP Data Integrity Definitions and Guidance for Industry (Draft versionfor consultation July 2016)

•FDA Draft Guidance for Industry: Data Integrity and Compliance with CGMP

•ICH Q9 Quality Risk Management

•ICH Q10 Pharmaceutical Quality System

•WHO Annex 5: Guidance on Good Data and Record Management Practices

&#8226IC/S Draft Guidance: Good Practices for Data Management and Integrity inRegulated GMP/GDP Environments (Draft 2 published August 2016)

ThisGuide provides a method for managing risk to record and data integrity.Regulated companies may already have established risk management activities andtools, and this Guide does not intend or imply that these existingmethodsshould be discarded, rather that they continue to be used as appropriate withinthe context of the overall risk management process described. Other methods ortechniques giving documented evidence of adequatecontrol, and ensuring appropriate security and integrity, may alsobe acceptable.

本指南提供了一种记录和数据的完整性基于风险管理的方法。受监管的公司可能已经建立了风险管理活动和工具，而本指南并不打算或暗示这些现有的方法应该被抛弃，而应该在描述的整个风险管理过程的范围内继续使用它们。其他提供有充分控制证据的方法或技术，并确保有适当的安全和完整性，也可以接受。

ThisGuide may also be useful in other regulated areas such as cosmetics and food,or in other areas or sectors where data integrity is important.

本指南也可能适用于其他受监管的领域，如化妆品和食品，或对数据完整性重视的其他领域或行业。

1.4 Structure of thisGuide本指南的结构

ThisGuide contains this introduction, a main body, and a set ofappendices.It has been structured to meet the needs of various readers, and contains, inincreasing level of detail:

这个指南包含了这个介绍，主体部分和一组附录。它的结构是为了满足不同读者的需求，并包含了越来越多的细节:

1.Data integrity requirements, critical areas of regulatory focus and concern,and key concepts

数据完整性要求，监管重点和关注的关键领域，以及关键概念

2.A framework for data governance and the importance of human factors

数据管理框架和人为因素的重要性

3.A complete data life cycle approach as part of a Quality Management System(QMS), from creation to destruction

一个完整的数据生命周期（从创建到销毁）作为质量管理系统(QMS)的一部分

4.Further information on how to apply the Quality Risk Management (QRM) approachfrom ISPE GAMP® 5 torecord and data integrity

进一步的信息是，关于从ISPEGAMP5到记录和数据的完整性，如何运用质量风险管理(QRM)方法

5.More detailed information, including “how to” guidance for specific topics, ina series of management, development, and operation appendices

更详细的信息，包括“如何”指导附录中特定的一系列的管理，开发和操作的主题

本文转自微信公众号：分析实验室 AnalyticalLab，陆续更新中......

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