AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER
Mar 172016
 

After the revision of the General Chapter on quality testing of sterile medicinal products in the US American Pharmacopoeia had already been announced last year in the USP 38-NF 33, the USP is planning a new revision. Read more about the revision of Chapter <1>.

http://www.gmp-compliance.org/enews_05240_Second-Revision-of-USP-Chapter–1–Injections-and-Implanted-Drug-Products–Parenterals–Product-Quality-Tests_15090,15160,15266,Z-PEM_n.html

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.

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

///////USP 38-NF 33, revision of Chapter <1>, quality testing of sterile medicinal products, monographs, USP,  new revision

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