Inside USP: Monograph Makeover Requires Industry Input - Pharmaceutical Technology

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Inside USP: Monograph Makeover Requires Industry Input
Monograph modernization and standards donation go hand in hand.


Pharmaceutical Technology
Volume 35, Issue 5, pp. 90, 94

By donating a monograph modernization procedure, the donor has a direct impact on setting the resulting USP standard, which provides an appropriate standard to be enforced by regulatory authorities. To acknowledge the generosity of donors, USP recently enhanced and expanded its Donor Recognition Program. Elements include a Certificate of Appreciation; public recognition (for those donors who wish to be recognized) in formats such as the USPNF or during scientific meetings; donor-specific progress reports; and complementary or discounted USP products and services.

To maintain consistency with FDA–approved specifications and control strategies, USP prefers to receive submissions from manufacturers of FDA–approved products (including drug substances and excipients used in FDA–approved products) or manufacturers seeking FDA approval. The latter category of submissions will be considered for publication as Pending standards. Submissions, especially new impurity procedures, from other sources (e.g., contract laboratories, academic institutions, analytical instrumentation or equipment manufacturers) will be accepted on a case–by–case basis and should follow the International Conference on Harmonization's Q3 guideline. Some modernization proposals may generate new USP Reference Standards, and USP invites the sponsor of the proposal to donate the necessary bulk reference materials.

Manufacturers may be concerned that updated monographs will lead to added costs for correspondingly upgraded equipment and processes. However, many manufacturers of the medications involved have already, of their own initiative, improved tests since the monograph was first published. These updates occur regularly as technologies and methods advance. In fact, USP is hoping to take advantage of these types of initiatives and growth so that they may be reflected in the compendia through updated tests and limits.

The partnership among USP, FDA, and CHPA represents a united front in the effort to safeguard public health. USP appreciates and strongly encourages widespread industry participation early in the monograph-modernization process.

For more information

Karen Russo, PhD, is vice-president of small molecules, and Shawn Dressman, PhD, is vice-president of standards acquisition, both at the US Pharmacopeial Convention (USP),
,
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