14/15 September 2021
In our GMP-News from 30 November 2011 we reported about the USP New Medicines Compendium.
This Medicines Compendium has also been developed for manufacturers who want to export to countries where regulatory requirements are almost inexistent or without national pharmacopeias.
The USP has now put these new standards online and for free. In doing so, the USP wants to contribute to improve the quality of excipients, APIs and medicinal products worldwide.
The written standards or monographs use a new scientific approach which differentiates itself from the other pharmacopoeias. The particularity of the MC monographs is the "performance-based" approach. The background for this is an article in the Pharmacopoeial Forum Vol. 35(3) from May-June 2009 entitled "Performance-based Monographs".
The drafts for new monographs are submitted for comments 90 days to all stakeholders.
It is particularly interesting to note that in case of monographs for APIs (respectively for the medicinal products derived from these) the data on validation are listed, too. Under the following link, you can see the example of "Acyclovir" and read the validation summary.
Via the New Medicines Compendium, you can access some of the General Chapters of the USP.
You will get more information about the new USP General Chapters at the ECA Conference "Compliance Update: EP, USP, and JP - Update on New Monographs - Dealing with Divergent Compendial Methods", from 21 - 22 June 2012 in the Corinthia Hotel in Prague.
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)