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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
The US Pharmacopeial Convention recently held its convention in Washington, DC.
On Apr. 21-24, the US Pharmacopeial Convention (USP) held its convention in Washington, DC. This gathering occurs once every five years, and the outcome sets the direction and course of USP for the next five-year revision cycle. USP's new revision cycle will begin on July 1, 2010 and last until June 30, 2015.
During the convention, delegates decided to cut its number of committees in half from 40 to 20. Forty individuals were slated to run for chairmanships, two for each available position. Of the 40 nominees, only 13 were from industry. In three instances, the two candidates running for the same position were both from industry.
Delegates also reviewed and adopted nine resolutions proposed for the 2010 convention. Three were of particular interest to the pharmaceutical industry. The first resolution called on USP to strengthen its core compendial activities, working collaboratively with industry, regulators, and stakeholders to produce relevant, timely, and accurate public standards. During the last five-year cycle, USP expanded its operations to India and China and focused a considerable amount of effort on international activities. This growth appears to have strained USP’s resources and may have contributed to the unprecedented recall of the USP–NF. For USP to regain industry confidence, the organization may need to reassure industry that it has the proper amount of resources devoted to monograph standards development before it undertakes additional collaborative activities.
Second, a resolution on strengthening USP’s relationship with the US Food and Drug Administration (Resolution 3) pledged greater USP collaboration with the agency and other public and private stakeholders. The goal is to explore mechanisms that would enable USP to provide and maintain up-to-date national standards for legally marketed drugs and excipients in the United States. Overall, industry seemed to support this resolution and believe it is critical for USP and FDA to work together. Convention delegates also discussed, however, how a focus on supply-chain knowledge, supplier qualification, and supplier auditing could offer additional product security.
Third, a resolution aimed at strengthening and expanding harmonization efforts (Resolution 5) urged USP to increase its collaboration with pharmacopeias, industry, regulators, international organizations, and other stakeholders around the world to develop global standards. A similar resolution was adopted during the last convention cycle but focused more on USP’s partnership with the Pharmacopeial Discussion Group and other pharmacopeias. The new resolution offered a different aaproach to the international harmonization efforts by involving “regulators, international organizations and other stakeholders” to assist with the harmonization effort.
USP and industry will address the resolutions from the convention during the next five years. A complete list of the organizations belonging to USP, the proposed resolutions, and FDA Commissioner Margaret Hamburg’s address are available on the USP website.
Susan J. Schniepp attended the USP Convention and is a member of Pharmaceutical Technology’s Editorial Advisory Board. Read her full convention report and commentary in the May 2010 issue of Pharmaceutical Technology.