Industry is actively pursuing its understanding of the supply chain and has taken several steps to share information among
themselves and their trade organizations to prevent adulteration. It would be more prudent for USP to let FDA and industry
work together to prevent adulteration and be ready to assist if and when the need arises for additional tests to be included
in monographs.
Third, a resolution aimed at strengthening and expanding harmonization efforts (Resolution 5) urged USP to grow 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 a bit more on USP's partnership with the Pharmacopeial
Discussion Group and other pharmacopeias. The concept of harmonizing monographs has been around since 1989. It wasn't until
the International Conference on Harmonization formed the Q4B Expert Working Group in 2004 that the industry saw progress made
toward realizing the goal of harmonized standards. The new resolution offers a different twist on the international harmonization
efforts by involving "regulators, international organizations and other stakeholders" to assist with the harmonization effort.
While USP's activities in the international arena are welcome, the organization needs to make sure it has enough resources
to manage the day-to-day operations of setting appropriate standards for the US pharmaceutical industry.
A few additional resolutions are worth noting. One (Resolution 4) aimed to support and advance global public health by collaborating
with national, regional, and global stakeholders. This particular resolution mentioned the expansion of USP's resources, something
the organization should consider so as to not compromise its core business—that is, the publication of the USP–NF.
Another (Resolution 6) revolved around establishing quality standards for food ingredients. The resolution indicated that
"USP should continue and expand its commitment to quality standards for food ingredients, working to strengthen the role of
Food Chemicals Codex (FCC) as a global compendium for food ingredients, increasing the number of documentary standards and
reference materials available for food ingredients, and exploring the feasibility and advisability of expanding the scope
of FCC." As with some of USPs other initiatives, this one is admirable but devoting the proper resources to this activity
is paramount for success. The pharmaceutical industry occasionally needs to use food-grade materials for formulation due to
the lack of a comparable pharmaceutical grade. It is important for USP to work with pharmaceutical experts as well as food
experts to set the correct requirements for these ingredients.
Five more years
The next five years will be exciting for both USP and industry as the resolutions from the convention are addressed. Industry
must demand that the quality and reliability of the USP–NF not be compromised as USP tries to assert itself as an international organization during the next revision cycle.
Additional sources
A complete list of the organizations belonging to USP, the proposed resolutions, and Dr. Hamburg's address are available on
the USP website at
http://www.usp.org/.
Susan J. Schniepp is president of Schniepp & Associates, a pharmaceutical consulting firm, sue.schniepp@mac.com
.
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