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USP章節(jié)<1>注射劑和植入藥品(靜脈)-藥品質(zhì)量測試第二版

Second Revision of USP Chapter <1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests
USP章節(jié)<1>注射劑和植入藥品(靜脈)---藥品質(zhì)量測試第二版

Last year already, the revision of the General Chapter on quality testing of sterile medicinal products was initiated in the USP 38 NF 33. The targeted official date for coming into force was the 1st May 2016. Now, the USP has announced that because of some comments received, there will be a further revision. This is due to the USP's intention to support in Chapter 1 both existing monographs as well as new monographs to be developed. The new scope should now be focussed again to avoid confusion. The publication is striven for March 2016 as well as the adoption of the changes in the USP 40 NF 35. Furthermore, USP has announced that also the contents of General Chapters <2> to <5> will be examined.
去年,無菌藥品質(zhì)量測試通則修訂版在USP38NF33上發(fā)布。原定生效日期為2016年5月1日,現(xiàn)在,USP宣布因為收到一些建議,會有進一步修訂。這是因為USP要在第1章里支持現(xiàn)有各論以及要研發(fā)的新各論。新的范圍現(xiàn)在應集中在避免混淆。期望新的版本能在2016年3月公布,并在USP40NF35中被采納。另外,USP已宣布將對通則<2>和<5>的內(nèi)容進行檢查。

On the USP website you will find further details regarding the revision of Chapter <1>.
在USP網(wǎng)站上,你可以發(fā)現(xiàn)關于第<1>章的更多細節(jié)。

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