USP Seeks Help from Industry for its Monograph Modernization Effort

The US Pharmacopeia (USP) is seeking help from drug manufacturers in its effort to update monographs for small molecules and excipients that use outdated technology, have safety/environmental concerns, or are missing key aspects.  The focus for “modernization” of excipient monographs will be to replace relatively non-specific identification procedures with more specific tests such as infrared spectroscopy.

USP announced on May 28 that it is seeking proposals to replace or add procedures for the 200 small molecule monographs and 96 excipient monographs it has prioritized as most in need of updating.

USP emphasized that “in order to maintain consistency with FDA-approved control strategies, it prefers to receive submissions from manufacturers of FDA-approved products…or manufacturers intending to seek FDA approval.”  Submissions from other sources will be considered on a case-by-case basis and should follow ICH Q3 guidelines.

The announcement follows a resolution that was adopted at the 2010 USP convention in late April calling for the pharmacopeia to “strengthen its focus on core compendia activities,” including updating monographs, during the next five year cycle.

More on the USP monograph modernization effort, including links to relevant documents, is available to subscribers on page 2.


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