MHRA的GMP检查新分析

New Analysis of GMP Inspections by MHRA

MHRA的GMP检查新分析

Due to the Freedom of Information Act (FOI), the FDA makes their inspection results available to the public. More rarely, however, the public gets informed about inspection results of EU supervisory authorities. The U.K. Medicines & Healthcare Products Regulatory Agency (MHRA) is a positive exception from this rule. Now, the 2016 GMP inspection deficiency data trend has been published by MHRA's GMDP Inspectorate.

由于自由信息法案（FOI），FDA会将其检查结果向公众发布。但是，EU监管当局向公众通报其检查结果的情况相对更少。英国药监（MHRA）则是一个正面的例外。现在，MHRA的GMDP检查团刚刚公布了其2016年GMP检查缺陷数据趋势。

According to MHRA they have "improved the way of gathering the inspection deficiency data". The new data trending can now allow stakeholders to identify:

根据MHRA的信息，他们已经“改进了收集检查缺陷数据的方式”。新的数据趋势现在可以让干系人找到：

• The severity and frequency by the EU GMP references
• 依据EU GMP所判定的缺陷严重性和频次
• The overall number of deficiencies by categories: Critical, Major, Other
• 按关键、重大和其它分类的缺陷的总计数量
• The high impact vs. high frequency issues
• 重大影响VS高频次问题
  

In 2016, the MHRA has inspected 242 UK manufacturers and performed 82 inspections overseas. In the top-ten list of "critical" and "major" deviations found in all inspected areas, findings regarding the quality system rank first. And there is a new number two: "Sterility Assurance", which wasn't even in the top ten in 2015 (see illustration 1). This is similar to recent FDA findings and the same number one as in the previous year.

2016年，MHRA共检查了242个英国生产商，实施了82次海外检查。在所有受检领域中发现的“关键”和“重大”缺陷前10清单中，关于质量体系的缺陷排位第一。位居第二的是一个新项目“无菌保证”，在2015年这甚至都没有排在前十位中（参见图1）。这类似于FDA最近的发现，数据则与去年数量相同。

Ranking 排名	Groups 类别	Critical 关键	Major 重大	Others 其它
1	Quality System 质量体系	38	449	772
2	Sterility Assurance 无菌保证	34	190	162
3	Production 生产	20	191	543
4	Complaints and Recall 投诉和召回	11	80	110
5	Qualification/Validation 确认/验证	10	123	232
6	Premises & Equipment 设施&设备	9	113	464
7	Computerised Systems 计算机化系统	9	44	120
8	Personnel 人员	8	42	150
9	Documentation 文件记录	2	166	646
10	Quality Control 质量控制（QC）	2	42	192

Most of the respective findings in Chapter 1 of the EU-GMP Guidelines (Pharmaceutical Quality System) refer to 1.4 describing the pre-requisites for an appropriate Pharmaceutical Quality System and 1.8 describing the Good Manufacturing Practices needed.

大多数相关的缺陷是在EU GMP指南第一章（PQS），参见1.4，其中描述了适当的PQS的前提，以及1.8，其中描述了所需的GMP。

Again, a lot of observations were made in the handling of deviations and CAPA, as can be seen in the examples given in the report. But also quite a few deficiencies related to the lack of senior management oversight on effective implementation of pharmaceutical quality system (PQS) and the Product Quality Review (PQR) were made. As in the previous year, the MHRA also focuses on ensuring that updates to EU GMP were captured, reviewed and implemented.

然后，在偏差和CAPA处理方面发现了大量缺陷，在报告的例子中可以看出。但还有一小部分缺陷是关于高层缺乏对PQS和PQR有效实施的监管。在前一年，MHRA也聚集于确保获取、审核和实施EU GMP的更新内容。

The report lists examples for all relevant chapters and annexes of the EU GMP Guidelines, allowing stakeholders to "perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement".

报告列出EU GMP指南所有相关章节和附录的例子，让干系人可以“针对缺陷执行自我评估，作为自检和持续改进的一部分”。

When it comes to Annex 16 for example (Certification by a Qualified Person and Batch Release), a Qualified Person (QP) can get a view on what is expected. And this year, some observations were made at the GMP/GDP interface:

例如讲到附录16（QP认证和批放行），QP可以知道官方要求是什么。2016年，关于GMP/GDP界面也发现了一些缺陷：

• "Arrangements for temperature monitoring of air shipments did not justify why data loggers were not required in every pallet."
• 空运温度监测安排没有论证为什么不需要在每个托盘上设置数据记录仪
• "Procedures allowed mean kinetic temperature (MKT) to be used to assess temperature excursions but did not require an investigation to be performed into the cause of the excursion."
• 程序使得MKT可以用于评估温度短时超标，但并没有要求对超标原因进行调查
• "Several products were routinely imported into the EU from the USA and stored at site for onward export to other third countries, however these were not subject to QP certification before being released for this export supply"
• 几个药品常规地从USA进口至EU，存贮在一个地方，之后再出口至其它第三国，但是，在放行出口之前没有经过QP认证