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欧盟GMP上面很怪的一段文字,如何理解?

时间: 2008-09-27 00:57:40 作者: 来源: 字号:
6.14  Reference samples from each batch of finished products should be retained till one year after the expiry date. Finished products should usually be kept in their final packaging and stored under the recommended conditions. Samples of starting materials (other than solvents, gases and water) should be retained for at least two years (2) after the release of the product if their stability allows. This period may be shortened if their stability, as mentioned in the relevant specification, is shorter. Reference samples of materials and products should be of a size sufficient to permit at least a full re-examination.
(2) In Federal Republic of Germany, France, Belgium and Greece, samples of starting materials should be retained for as long as the corresponding finished product。

为什么对联邦德国、法国、比利时、希腊作出特殊规定啊。
the question is so difficult, i guess no one can help you.
有可能跟他们自己国家的特殊规定有关系。
大家该回答岗位了吧,继续求助啊
估计这几个国家的GMP有特殊规定。
看来为了弄明白这个问题,需要彻底研究联邦德国、法国、比利时、希腊的GMP了;

估计研究完了,欧盟gmp又修改称,一律按照欧盟文本正文执行了。
继续求助啊
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