USP对于2-8度超温的规定

benifitpz

大家好，在论坛上看到对于贮藏或运输过程中温度超标的评估，有蒲友建议看USP，另外ECA也有对发运温度异常的产品放行建议，有人有这两份东西吗？或者有文章的名字也行，谢谢

呼呼_802

里面描述了一下

罗伊鲱

In a recent blog of the Medicines and Healthcare products Regulatory Agency (MHRA), the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations.

In the blog, MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU:

"The label claim for the product is 'store below 25°C', and the excursion was up to 29°C for 3 days. Existing stability data demonstrated no issues when stored at 30°C for up to 3 months. This situation would fall within the scope of 'unexpected deviations', provided that the shipment process was designed to comply with the registered conditions (i.e. that the excursion could be reasonably described as 'unexpected')." That does mean that the Qualified Person (QP) would be in a position to certify the batch.

However, MHRA states, "if there were no controls over shipment conditions, then the use of stability data as a 'routine' means to justify such an excursion would not be acceptable."

To find out more please see the MHRA nspectorate's blog "Handling of unexpected deviations".

罗伊鲱

参考https://www.ouryao.com/thread-128649-1-1.html

USP38s2<659>: http://wenku.baidu.com/view/1683e36fe009581b6ad9eb4f.html


补充内容 (2017-1-5 16:47):
MKT值应该如何评价药品质量？
https://www.ouryao.com/forum.php?mod=viewthread&tid=50065

罗伊鲱

https://www.ouryao.com/forum.php? ... DB8MTE0MzJ8MzAzODI2

qqqqqqqqqqqq

roadman 发表于 2017-1-5 14:40
参考https://www.ouryao.com/thread-128649-1-1.html

USP38s2: http://wenku.baidu.com/view/1683e36fe00 ...

1111111111111111

pharm180

那这批运输产品怎么办？

meiyududu

谢谢分享。。。