20150218 ECA新闻：GMP数据完整性：新的MHRA指南

20150218 ECA新闻：GMP数据完整性：新的MHRA指南  

2015-02-27 20:07:32|  分类： ECA新闻

GMP News
18/02/2015

GMP Data Integrity: New MHRA Guideline

GMP数据完整性：新的MHRA指南

The MHRA announced in January 2014 that the pharmaceutical industry is expected to review data integrity within the frame of self inspections.

MHRA于2014年1月宣布制药行业应在自检时审核其数据完整性。

Now, a Guideline of the MHRA on data integrity was published in January 2015. According to the MHRA, data integrity in a pharmaceutical quality management system is fundamental to ensure that the medicinal products are of the quality required.

现在，MHRA于2015年1月公布了一份关于数据完整性的指南。根据MHRA的指南，药品质量管理体系中的数据完整性是一个基本要素，用以保证药品符合所要求的质量。

The Guideline describes MHRA's expectations for data in the GMP environment of pharmaceutical companies. These requirements should complete the existing regulations from the EU GMP and Eurdralex Volume 4.

指南中描述了MHRA对制药公司GMP环境下数据的期望。这些要求是对已有欧盟药品法卷4里EU GMP的规定的完善。

The MHRA expects a so-called "data governance system". No forensic approach to data checking is expected but a system should be developed and run which gives an acceptable state of control based on the data integrity risk. This system should be fully documented and have a "supporting rationale"!

MHRA期望具备所谓的“数据管理系统”。不需有司法的方式来对数据进行检查，但应开发和运行一个系统保证基于数据完整性风险的控制状态可以接受。该系统应全面记录，并具有“支持合理性”。

The requirements apply to both manual (paper) and electronic data. "Manufacturers and analytical laboratories should be aware that reverting from automated / computerised to manual / paper-based systems will not in itself remove the need for data integrity controls." A marketing authorisation holder is expected to implement scientific and technical progress.

要求同时适用于人工（纸质）和电子数据。“生产商和分析化验室应明白从自动/计算机化转为手工/纸质系统并不会自动消除对数据完整性控制的要求”。上市许可持有人应所实施的措施应符合科学和技术的进步。

For further information please see the MHRA's complete document (15 pages) GMP Data Integrity Definitions and Guidance for Industry January 2015.

详细信息参见MHRA完整文件（15页）“GMP数据完整性定义和行业指南，2015年1月”。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201512623056827/

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