Modernisation of USP Monographs

In our GMP News from 2 December 2009, we reported about the USP White Paper "USP's Role in Setting Enforceable Quality Standards for Medicines" in which it is said that the USP does not get enough support from the pharmaceutical industry in the creation and revision of monographs.

Research companies have not shown interest in having standards of their products to be laid down in the USP as this would facilitate work for generic manufacturers. The latter could indeed easily refer to a single monograph instead of elaborating their own specifications and testing methods for APIs - and in the USP also for many dosage forms.

On the other hand, if the original manufacturer waits too long, a generic manufacturer could submit a monograph to the USP after the expiration of the patent-acquisition period. If so and the monograph is integrated in the USP, the original manufacturer would have to work according to these specifications!

On 28 May 2010, the USP announced the intention to modernise the official monographs for APIs (small molecules) and for excipients. Please see the complete USP announcement for further information.

Among other things, the update of monographs must consider the following monographs to be revised:

• Those which refer to the use of obsolete technologies
• Monographs which - from today's perspective - could be worrying in regard to safety and environment
• Those where methods regarding essential aspects like impurities are missing.

The monographs in need of revision have been listed by the USP in a spreadsheet. The spreadsheet "Monographs in Need of Modernization" was updated on 26 April 2011. 

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)