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Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.
Answering the calls of regulators and pharmaceutical manufacturers, the US Pharmacopeial Convention (USP) recently launched an initiative to identify standards in the USP-National Formulary (NF) compendia that maybe outdated, and to modernize them. USP will direct substantial energy and resources toward this effort during its 2010-2015 cycle, which commenced following the USP Convention meeting in April 2010. Key to the organization's success on this project—which will ultimately benefit patients, practitioners, manufacturers, and regulators—will be the participation of the pharmaceutical industry. USP hopes to collaborate closely with industry on this important activity.
The monograph modernization initiative is an outgrowth of feedback that USP has received during the past few years indicating that the organization should focus not only on developing new standards for medicines and their ingredients, but also on updating existing standards. This modernization effort will concentrate on small molecule and excipient monographs as well as certain biologics.
Updates to the monographs included in this effort are necessary for a variety of reasons—use of outdated technology (e.g, packed gas chromatography columns), existence of safety/environmental concerns (e.g, chlorinated solvents), or missing procedures for key aspects such as impurities, among others. Attention to monograph updating has been increasing, reflecting the reality that some of these monographs are roughly 40 to 50 years old. There are significant issues that need to be addressed within the monographs, and USP consequently views the project as a vital public health activity. This sentiment has been echoed by the US Food and Drug Administration. Commissioner Margaret Hamburg noted at the 2010 USP Convention in April 2010 that "one of the most pressing tasks before us [is] updating monographs... Now, we must jointly identify drug ingredients and products that would benefit from an up-to-date monograph... starting with those that have the greatest impact on public health."
As a starting point on this stepped-up effort, USP prioritized a list of 200 small molecule and 96 excipient monographs from the more than 4000 standards included in the USP-NF and posted the list on its website (accessible at www.usp.org/USPNF/submitMonograph/improveMon.html). USP examined data on patient use of the medicines (indicating public health impact), as well as the level of use of the monographs by the pharmaceutical industry (indicating manufacturer reliance on these standards). Monographs identified for updates cut across all therapeutic categories. The list is presented on the USP website as a downloadable spreadsheet, which includes information on what procedure needs modernization and the current status of the modernization. Some monographs have more than one procedure in need of modernization. USP is updating the monograph status on this list on the last Friday of every month.
Although USP is using its own laboratories to support this activity, active participation by industry is encouraged, and considered absolutely essential to accomplish the goals set forward. USP hopes this participation will take several forms, including donation of procedures with supporting validation data and associated bulk reference standard material (for situations in which new reference standards are introduced), as well as involvement in the public review process.
Submission of modernization proposals and donor recognition
Parties wishing to support the updating of standards can submit monograph modernization proposals to USP and donate associated reference standards. To maintain consistency with FDA-approved control strategies, USP prefers to receive submissions from manufacturers of FDA-approved products or manufacturers intending to seek FDA approval (the latter category of submissions will be initially considered for publication as a pending standard through USP s Pending Monograph process). Submissions, especially new impurity procedures, from other sources (e.g., contract laboratories, academic institutions, and analytical instrumentation/equipment manufacturers) will be accepted by USP on a case-by-case basis. Additional information about submitting proposals is available at www.usp.org/pdf/EN/USPNF/revisionRequestChecklist.pdf.
Recognizing the importance of industry contributions, USP recently expanded its Donor Recognition Program. Under the program, qualifying donors of monographs and reference materials are recognized through a portfolio of options. For example, donors may be recognized in USP publications and at the USP Science & Standards Symposium, formerly known as the Annual Scientific Meeting. In additon, donors may receive complimentary or discounted registrations to the USP Science & Standards Symposium; complimentary workshop registrations; a complimentary print subscription to USP-NF, the Food Chemicals Codex (FCC), or Dietary Supplements Compendium; complimentary registration for an on-site USP Pharmacopeial Education course; one-year, multiple-user license of electronic USP-NF or FCC; and complimentary USP Reference Standards. The expanded program is meant to acknowledge that the development of quality standards is truly a cooperative and collaborative effort. In USP s mission to protect public health through the establishment and maintenance of quality standards, USP appreciates the vital participation of industry.
One of the most important elements of the monograph modernization effort will be the public review of modernization proposals. All proposals will be published in the Pharmacopeial Forum (PF), the vehicle through which USP develops and revises USP-NF standards, and will follow USP s established process for public review and comment. Because any single proposal for modernization has the potential to impact the industry significantly (manufacturers will be required to comply with updated standards upon their effective date), USP would like to emphasize the importance of reviewing submissions to PF and encourages manufacturers to provide comments. More information about the program is available at www.usp.org/USPNF/submit-Monograph/improveMon.html.
Karen A. Russo, PhD, is vice-president, small molecules, at the US Pharmacopeial Convention (USP).