数据完整性----来自PIC/S和EMA的两个新文件

20160811 ECA新闻：数据完整性----来自PIC/S和EMA的两个新文件

GMP News
11/08/2016

Data Integrity - two new documents from PIC/S and EMA

数据完整性----来自PIC/S和EMA的两个新文件

In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity. Many draft guidances from different authorities were published in 2016. In April 2016, the American FDA issued a first draft Guidance for Industry - "New FDA Draft Guidance Data Integrity and Compliance with cGMP" -  and in July 2016, the British MHRA issued a third draft - " MHRA GxP Data Integrity Definitions and Guidance for Industry - Draft version for consultation". On 10 August 2016, the PIC/S followed with a first draft "Good Practices for Data Management and Integrity in regulated GMP/GDP environments" and simultaneously the European Medicines Agency (EMA) extended their 'Questions and answers: Good Manufacturing Practices' webpage by 23 answers on Data Integrity questions.

在最近两年，全球各国的国家药监局都越来越关注数据完整性。在2016年不同药监局发布了许多指南草案。在2016年4月，美国FDA发布了首份行业指南----“新FDA指南草案：数据完整性和CGMP符合性”，2016年7月，英国MHRA发布了第三稿---“MHRA GXP数据完整性定义和行业指南----修订后征求意见稿”。2016年8月10号，PIC/S跟着发布了首稿“受法规约束的GMP/GDP环境下数据管理和完整性优良规范”，而EMA将其 “问答：GMP” 网页上与数据完整性相关的问题增加了23个。

PIC/S 041-1 "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”

The current PIC/S draft document PI 041-1 contains 41 pages of detailed information. The document was written to provide guidance for inspectorates. The comment period for PIC/S Participating Authorities will end on 28 February 2017. The following activities have not been defined yet.

现行PIC/S草案PI 041-1包括41页详细信息。文件编制是为检查员提供指南。征求意见截止日期为2017年2月28日。但以下活动并未定义：

The introduction referred to the fact that the effectiveness of inspection processes is determined by the veracity of the evidence provided to the inspector and ultimately the integrity of the underlying data. Furthermore 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. Therefore 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.

前言指出了检查过程有效性是由提供给检查人员的证据真实性以及背后数据的完整性决定的事实。另外，对于检查过程来说，检查员是否可以确定和全面依赖于受检方呈现的证据和记录的准确性和完整性是非常关键的。因此优良的数据管理规程对生产商所产生和记录的所有数据的完整性的影响以及这些规范本身应保证数据是准确、完整和可靠的。

The first third of the document introduces 3 basic principles:

文件的前三分之一介绍了3个基本原则：

• Data governance system
• 数据管理体系
• Organisational influences on successful data integrity management
• 公司对成功的数据完整性管理的影响
• General data integrity principles and enablers
• 一般数据完整性原则和工具
  

The main part of the document focuses on the topics "Specific DI considerations for paper-based systems" and "Specific data integrity considerations for computerised systems". Here you can find the expectations of inspectors for different items. Each item will discussed in relation to "potential risk of not meeting expectations / items to be checked".

文件的主要部分关注了“纸质系统中具体DI考虑”和“计算机化系统中具体数据完整性考虑”两个问题。这里你可以发现检查者对不同项目的期望。每个项目将与“不符合要检查的期望/项目的潜在风险”结合一起讨论。

At the end of the document you will find 4 additional chapters on

文件最后部分，你会发现4个附加章节：

• Data integrity considerations for outsourced activities
• 外源活动的数据完整性考虑
• Regulatory actions in response to data integrity findings
• 针对数据完整性缺陷的法规措施
• Remediation of data integrity failures
• 数据完整性失败的弥补
• Definitions
• 定义
  

EMA Questions and answers: Good Manufacturing Practice EMA问答：GMP

For many years, the European Medicines Agency (EMA) has been publishing a list of answers to frequently asked questions regarding Good Manufacturing Practice. The answers were discussed and agreed by the 'Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. Therefore the answers could be interpreted as an official EU statement to open GMP questions. Basically the answers are given to questions in relation to different chapters and annexes of the EU GMP guide. Furthermore there will be answers to topics like 'general GMP', 'GMP certificates' and 'inspection coordination'. On 10 August 2016, the EMA extended the list by detailed answers on 23 questions to Data Integrity, Data Lifecycle and related topics.

许多年来，EMA已经公布了一系列GMP常见问题的回复。这些回复均经过“GMP/GDP检查员工作组”讨论和同意。因此回复可以被看作是GMP问题的EU官方声明。一般来说，回复的问题是与EU GMP指南不同的章节和附录相关的问题。此外，也有一些主题如“通用GMP”、“GMP证书”和“检查协调”。在2016年8月10日，EMA在其问答中增加了23个关于数据完整性、数据生命周期和相关主题的回复。

Sources: 来源

PIC/S PI 041-1 "Good Practices for Data Management and Integrity in regulated GMP/GDP environments"

EMA Questions and answers: Good Manufacturing Practice