Inside USP: Positioned for Growth - Pharmaceutical Technology

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Inside USP: Positioned for Growth
USP membership meeting prepared the standards-setting body to meet modern challenges.

Pharmaceutical Technology
Volume 6, Issue 34, pp. 56, 60

Dr. Hamburg's remarks preceded a vote by USP delegates on a series of resolutions that will guide the organization for the next five years. One resolution aims to strengthen USP's relationship with FDA, by working with the agency and other public and private stakeholders to explore mechanisms to enable USP to provide and maintain up-to-date national standards for legally marketed drugs and excipients in the US. Other adopted resolutions are of interest to the pharmaceutical industry as well. One involves strengthening USP's focus on core compendial activities by working collaboratively with academia, industry, regulators and other stakeholders, and by using a robust quality management system within USP and its Council of Experts, to ensure relevant, timely, and accurate public standards. Another focuses on strengthening and expanding harmonization efforts by working with pharmacopoeias, industry, academia, regulators, international organizations, and other stakeholders to develop global standards. Additional resolutions focused on issues such as standards for compounded medicines, dietary supplements, and food ingredients.

Other important work relevant to industry included the election of the USP Council of Experts, which will be responsible for establishing the standards for medicines, dietary supplements, and food ingredients of USP during the next cycle. These standards help ensure the identity, as well as the strength, quality, and purity of products and ingredients in the US and in countries where USP standards are used. Members of the Council of Experts serve as the chairs of 20 individual USP Expert Committees, which focus on standards development in specialized areas such as small-molecule medicines, biologics and biotechnology, and general chapters. The independent, scientific experts who are responsible for developing new and revising existing quality standards to reflect modern, relevant and up-to-date science are truly the backbone of USP.

The 2010 meeting continued the tradition of collaboration that is the very foundation of the event (and of USP). Overall, the nine resolutions—all adopted—further reinforced the need for cooperation in light of modern challenges by calling on USP to work with industry and others to promulgate the best possible standards for medicines and ingredients. As in the past, USP will continue to seek the expertise of industry through participation in Expert Committees, acquisition of new standards, and other activities. The organization looks forward to another five years of working together to advance public health through quality medicines.

Full information about the convention, including resolutions, key reports and presentations, and a list of the Council of Experts' members, is available at

Roger L. Williams is chief executive officer of the US Pharmacopeial Convention in Rockville, MD,


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