Inside USP: Annual Scientific Meeting Recap - Pharmaceutical Technology

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Inside USP: Annual Scientific Meeting Recap
Representatives from 17 nations sit down to decide upon standards-setting initiatives.


Pharmaceutical Technology




Although the phrase "annual scientific meeting"may have a stilted connotation in the United States, the USPharmacopeia (USP)has taken the yearly event to a new level by going international. For several years, the organization has developed US-based annual scientific meetings, including its recent September meeting in Tampa, but USP now plans to hold annual scientific meetings abroad at its various global sites. Meetings already were held in India last February, and in September, the organization held a meeting during the opening of its Shanghai, China, office.

In addition, USP's Board of Trustees recently authorized the establishment of a USP site in São Paulo, Brazil, where a regional annual scientific meeting is tentatively scheduled for next summer. USPalso plans to meet in the Middle East next fall.

Although USPis extending its global presence, its largest audience is still in the US. Approximately 300 delegates attended the 2007 scientific meeting in Tampa. Delegates represented US and international pharmaceutical companies, regulatory bodies such as the US Food and Drug Administration and Council of Europe, as well as regulatory and industry organizations in Brazil, Mexico, Japan, the United Arab Emirates, and the United Kingdom. Stakeholders represented 17 nations.

The following provides an overview of the 2007 meeting, including its three most popular tracks.

Topics and tracks

This year's two-day meeting was unique compared with past years because the number of speakers in each session was limited to allow more detailed presentations and longer discussion sessions. Participants could customize their agenda by choosing among five tracks: Quality of Manufactured Medicines—Monographs and Reference Standards; Quality of Manufactured Medicines—General Chapters and Performance Testing; Quality of Manufactured Medicines—Biologics and Biotechnology; Quality of Care; and International Health.

The opening plenary included a number of USP organizational reports. Among the most noteworthy were:the board's authorization of USP's acquisition and publication from March 2008 of Food Chemicals Codex (FCC), and, as noted, the launch of a site in Brazil; the Council of Experts' ongoing work to revise the General Notices of the United States Pharmacopeia–National Formulary and FCC; and a stakeholder report that commented on revisions to "Residual Solvents" <467>, monograph redesign, harmonization, and salt nomenclature, among other topics.

Two plenary speakers addressed current topics in biologics and genomics. Both expressed confidence that advances in proteomics and genomics may positively affect public health. They, however, were also concerned about overly optimistic projections and the absence of standards as biotechnology products and diagnostics move beyond the laboratory into public commerce.

The second day's plenary consisted of presentations by USP's executive vice- president–chief executive officer(EVP–CEO), chief science officer, and chief reference materials officer. The EVP-CEO spoke about core scientific initiatives at USP, particularly the quality of manufactured and compounded foods and medicines and how manufacturers can demonstrate that their products are equivalent to approved products. Because FCC is not an official compendium of the US, establishing standards for food ingredients remains a challenge. One solution would be to move FCC to official status in US regulations.

The chief science officer commented in detail about USP's continuing work on "Residual Solvents" <467>, "Heavy Metals" <231> (bearing in mind that by one estimate the periodic table contains approximately 72 metals of pharmaceutical interest), flexible monographs, and related monograph-related topics. Finally, the chief reference materials officer highlighted the evolution of standards and standards-setting procedures beginning with putative anthropomorphic units (the supposed length of a monarch's foot) to crude physical marks (e.g., two spikes in a stick, used to make scratch marks that represented a meter) to vibrational units (the wavelength of an elemental spectrum) to current concepts about the speed of light in a vacuum. A unifying theme among the speakers was the need for metrologically informed standards that are developed by an international public process of review and comment.


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