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标题: USP章节<1>注射剂和植入药品（静脉）---药品质量测试第二版 [打印本页]

作者: 毛毛 时间: 2016-3-19 03:04 PM
标题: USP章节<1>注射剂和植入药品（静脉）---药品质量测试第二版

20160316 ECA新闻：USP章节<1>注射剂和植入药品（静脉）---药品质量测试第二版

http://www.gmp-compliance.org/enews_05240_Second-Revision-of-USP-Chapter--1--Injections-and-Implanted-Drug-Products--Parenterals--Product-Quality-Tests.html

GMP News
16/03/2016

Second Revision of USP Chapter <1>Injections and Implanted Drug Products (Parenterals)-Product Quality Tests

USP章节<1>注射剂和植入药品（静脉）---药品质量测试第二版

Last year already, the revision of theGeneral Chapter on quality testing of sterile medicinal products was initiatedin the USP 38 NF 33. Thetargeted official date for coming into force was the 1st May 2016. Now,the USP has announced that because of some comments received, there willbe a further revision. This is due to the USP's intention to support in Chapter1 both existing monographs as well as new monographs to be developed. The newscope should now be focussed again to avoid confusion. The publication isstriven for March 2016 as well as the adoption of the changes in the USP 40 NF35. Furthermore, USP has announced that also the contents of General Chapters<2> to <5> will be examined.

去年，无菌药品质量测试通则修订版在USP38NF33上发布。原定生效日期为2016年5月1日，现在，USP宣布因为收到一些建议，会有进一步修订。这是因为USP要在第1章里支持现有各论以及要研发的新各论。新的范围现在应集中在避免混淆。期望新的版本能在2016年3月公布，并在USP40NF35中被采纳。另外，USP已宣布将对通则<2>和<5>的内容进行检查。

On the USP website you will find furtherdetails regarding the revision of Chapter <1>.

在USP网站上，你可以发现关于第<1>章的更多细节。

http://zhuyujiao1972.blog.163.co ... 472720162169223284/

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