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标题: 新的WHO草案“优良数据和记录管理” [打印本页]

作者: aiyao 时间: 2015-11-16 04:34 PM
标题: 新的WHO草案“优良数据和记录管理”

20151111 ECA新闻：新的WHO草案“优良数据和记录管理”

GMP News
11/11/2015

New WHO Draft on "Good Data andRecord Management"

新的WHO草案“优良数据和记录管理”

After several FDA Warning Letters wereissued in the last 2-3 years, regulatory authorities have set their focuson the data integrity topic - see also our News "Data Integrity: New Inspection Focus ofthe FDA." Both the PICS and the FDA are elaborating newguidelines on the topic; the English MHRA has already published an ownGuideline - see also our News "GMP Data Integrity: New MHRA Guideline".

过去两三年FDA签发了几封警告信之后，法规当局将其焦点聚集到了数据完整性问题上---参见我们的新闻“数据完整性：FDA新检查焦点”。PICS和FDA正在起草关于此主题的新指南；英国MHRA已经公布了其自己的指南---参见我们的新闻“GMP数据完整性：新MHRA指南”。

Now, the WHO has released the draft of aguideline - after a one-year development phase - "Good Data and RecordManagement Practices" which can be commented on until 30 November2015.

现在，WHO公布了其指南草案---在一年的起草后，“优良数据和记录管理规范”现在公布征求意见，截止日期为2015年11月30日。

A substantial part of the decisionstaken by the authorities with regard to the regulated industry are based ondossiers. For this reason, their data have to meet the ALCOA principles(Accurate / Legible / Contemporaneous / Original / Attributable). Althoughthose principles aren't new, an increasing number of observations with regardto "Good Data Management" in the area of GMP, GCP and GLP have beenmade during inspections in the last years. The reasons for this are manifold.

药监当局做出关于法规行业的决定基本是出于文件审核。因此，其中数据必须符合ALCOA原则（准确、清晰、同步、原始、可追溯）。尽管这些原则并不是新要求，但在过去几年对GMP、GCP和GLP检查期间发现越来越多的关于“优良数据管理”的缺陷。其理由则多种多样。

The present WHO draft on "Good DataManagement" should bring together all the existing normative principlesand close the gaps left behind in the current guidelines. The focus is on thoseprinciples which are already listed in existing WHO guidelines and which havean influence on data integrity and reliability.

现在的WHO草案“优良数据管理”应将所有已有的规范原则合在一起，弥合现有指南之间的漏洞。其重点是已列在现有WHO指南中的那些原则，以及对数据完整性和可靠性有影响的原则。

The draft itself is sectioned asfollows:

草案本身包含以下部分：

· Introduction and background

· 概述和背景介绍

· Aims and objectives of this Guidance

· 指南目的和目标

· Glossary

· 术语

· Principles

· 原则

· Quality risk management to ensure Good Data Management

· 确保优良数据管理的质量风险管理

· Management governance and quality audits

· 管理和质量审计

· Contracted organizations, suppliers, and serviceproviders

· 合同组织，供应商和服务提供方

· Training in Good Data and Record Management

· 优良数据和记录管理培训

· Good Documentation Practice

· 优良文件记录规范

· Designing Systems to assure data quality and reliability

· 设计系统以确保数据质量和可靠性

· Managing data and records across the data lifecycle

· 在数据生命周期中管理数据和记录

· Addressing data reliability issues

· 讨论数据可靠性问题

· References and further reading

· 参考文献和深入阅读

Delegates and former delegates of ECAevents as well as ECA members have access to theMembers Area where the WHO Guidance on GoodData and Record Management Practices can be downloaded.

参加过ECA会议的的代表和前代表以及ECA成员可以进入成员区，下载WHO的优良数据和记录管理规范指南。

来源：http://zhuyujiao1972.blog.163.co ... 272015101110452616/

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