ECA新闻：欧盟检查数据库中发布的GDP不符合报告

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GDP Non-compliance Report issued in EudraGMDP

欧盟检查数据库中发布的GDP不符合报告

The competent authority of the Czech Republic entered a GDP non Compliance Report into the community database for GMP and GDP compliance. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often.

捷克共和国药监在欧盟GMP和GDP符合性数据库中录入了一份GDP不符合报告。虽然GMP不符合性报告经常看到，但GDP符合性问题还是比较少的。

The concerned company is First Pharma s.r.o. The warehouse is in Alliance Healthcare s.r.o., Podle Trati c.p. 624/7, Praha 10 - Male?ice, 108 00, Czech Republic. According to the inspectors: "From the knowledge gained during inspection of this wholesale distributor, the latest of which was conducted on 2016-04-21, it is considered that it does not comply with the Good Distribution Practice requirements referred to in Article 84 of Directive 2001/83/EC." No further details have been published about the details of the findings.

其中涉及的公司是First Pharma s.r.o.，是位于捷克的一个仓库。根据检查员的说法，“从2016年4月21日检查期间获得的此批发商的信息来看，认为它不符合指令2001/83/EC第84条中所述的GDP要求。”关于缺陷没有更详细的信息。

Still, GDP Non-Compliance Reports in EudraGMDP are an exception. But this does not mean that inspections always confirm the GMP status. The simple reason is the lack of data entered into the database. This becomes obvious when one looks at the country data entered into the database. Germany counts only 73 GDP compliance reports. And this is only a fraction of the total number issued. The same applies for many other countries as well. Still, the EU needs to work on the procedure to make sure that both GDP compliance and GDP non compliance data will be entered by the competent authorities in the EU. Only if data entry is made complete the goal of the database can be achieved. For example, wholesalers and pharmaceutical companies can then use the database to check whether customers or suppliers have a valid GDP certificate.

在欧盟检查数据库中的GDP不符合报告仍然还只是少数。但它并不表示检查总能通过。简单的原因是数据并没有录入数据库。当我们查看数据库里的国家数据时，可以很明显地发现这一点。德国只有73个GDP符合性报告，但这只是所签发的总数中的一部分。同样，其它许多国家也一样。EU还需要在程序上进行改进，确保EU国家药监会将GDP符合性和GDP不符合性数据录入数据库。只有数据录入完整，数据库才能达到其目的。例如，批发商和制药公司可以使用数据库来查询是否客户或供应商具备有效的GDP证书。

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GDP与GMP有何关系？