20150722 ECA新闻：GMP数据完整性----新MHRA博客

20150722 ECA新闻：GMP数据完整性----新MHRA博客

GMP News
22/07/2015

Integrity of GMP Data - New MHRA Blog

GMP数据完整性----新MHRA博客

According to the MHRA, the integrity of data in a pharmaceutical quality management system is so fundamental, because only this ensures that the medicinal products meet the required quality.

根据MHRA的观点，药品质量管理系统的数据完整性非常重要，因为只有保证数据完整性才能保证药品符合所需的质量。

In addition to the existing Data Integrity Guideline the MHRA has now developed a new blog because the authority considers this topic so important. In total, there will be three blogs on this topic. The first blog has been online since 25 June 2015.

考虑到其重要性，除了已有的数据完整性指南外，MHRA现在又开通了新的博客。总体来说，现在关于此专题将会有三个博客。第一个博客已于2015年6月25日上线。

In the last two years there have been many reports on the integrity of data in the pharmaceutical media. Authorities had to take action after there were corresponding failures at pharmaceutical companies, which resulted in the recall of products, supply shortages and in a tremendous damage of the affected companies' reputation.

在过去两年中，在药物相关的媒体中已有了很多数据完整性的报道。官方在发现药企未能符合相关要求后，会采取措施，这会导致召回药品、供应短缺以及受影响公司声誉的巨大损失。

The MHRA emphasises that this topic is not a new requirement, because the basic requirements for the integrity of data are already included in the international GMP regulations.

MHRA强调说该问题并不是一个新的要求，因为数据完整性的基本要求已包括在国际GMP法规中了。

From the MHRA's perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. But the MHRA's experience has shown that the majority of cases has to do with bad practices, poor organisational management or with weak systems which open possibilities for data manipulations.

MHRA认为对此最大的误解是检查失败仅仅是由于蓄意造假引起的。但是MHRA的经验表明大部分案例实际与操作实践不好、组织管理差及存在数据伪造可能性的薄弱系统有关

The pharmaceutical companies are now required to implement appropriate measures and technical processes to significantly improve their systems.

制药企业现在需要实施适当的措施和技术来显著提升其系统。

For more detailed information please see the full MHRA blog Good manufacturing practice (GMP) data integrity-a-new-look-at at old-topic-part-1.

更多详细信息，参见MHRA博客GMP数据完整性---老调新谈第1部分完整内容。

Source: MHRA, UK

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