EMA GMP/GDP IWG年度报告（2018-07）

beiwei5du

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017

一沙一叶

现在GDP的内容也有啊

一沙一叶

印度119，中国39，数量差距还是比较大的

qdyun

yuan_shibin

学习学习！！！！！！！！！！

beiwei5du

EMA GMP Inspections of Chinese Plants and Noncompliance Rate Fall Again

EMA conducted 29% fewer good manufacturing practice (GMP) inspections of Chinese plants last year than in 2016. The dip continues the downward trend seen in recent years.

In 2015, the first year EMA shared a geographic breakdown of its GMP inspections, the regulator assessed 72 facilities in China. The figure fell to 55 in 2016 and dropped to 39 last year. That means the number of Chinese manufacturing facilities inspected by EMA has fallen by almost 50% since 2015.

The downward trend has coincided with a reduction in the rate of GMP non-compliance. Of the 72 plants inspected by EMA in 2015, six failed to meet GMPs, resulting in a non-compliance rate of 8%. The figure dipped slightly in 2016 before dropping sharply last year, when one of the 39 inspections led to a GMP non-compliance statement. That amounts to a non-compliance rate of less than 3%.

EMA’s retreat from China covers a period in which its overall GMP inspection activity and interest in other countries has fluctuated. The overall number of EMA GMP inspections of plants based in third countries increased last year, moving the figure back up toward the high hit in 2015. The number of inspections of plants in India and the United States followed the same pattern, dipping in 2016 before rising back toward their former levels last year.

The Good Manufacturing and Distribution Practice Inspectors Working Group published the data in its 2017 annual report this week. Unlike many recent reports from EMA units, the document makes no mention of the current or forecast impact of Brexit on its operations.

syhorchid

学习一下

asynut

谢谢分享学习

lzw0813

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晚安

学习学习，感谢分享

applen2013

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胜利者

学习

hongyu

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xmango

请教个问题，不知EMA和EDQM是怎么算每年这个周期的，从哪月到哪月啊？

ttklsm

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小金库

谢谢分享。