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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.
Defining the Next Five Years.
On Apr. 21–24, the United States Pharmacopeial Convention (USP) held its convention in Washington, DC. This gathering of pharmacopeial minds occurs once every five years and the outcome sets the direction and course of USP for the next five-year revision cycle (July 1, 2010 to June 30, 2015).
Susan J. Schniepp
Before discussing some of the significant happenings that took place at this convention, it's worth recapping some facts about USP. The independent, standard-setting organization was founded in 1820, long before the pharmaceutical industry came into existence. At that time, pharmacists were essentially the drug manufacturers of their time. Still today, many USP convention members are from the pharmacy community. Other members represent: US colleges and schools of medicine and pharmacy; state medical societies and pharmacy associations; national and state professional and scientific organizations; governmental bodies; health science and other foreign organizations and pharmacopeias; consumer organizations and individuals representing public interests; and manufacturers, trade, and affiliated associations.
These member organizations name individuals to represent their specific interests at the convention. Delegates are responsible for voting on changes to USP's constitution and bylaws, voting on nominees to the Board of Trustees, voting on nominees to chair the USP expert committees, and debating and voting on resolutions. Of these responsibilities, the two that have the greatest significance to industry are electing the committee chairs—who then set the standards of the USP–National Formulary (NF)—and voting on proposed resolutions, which define USP's strategic direction.
Chairs and committees
For the 2010-2015 revision-cycle, USP cut in half its number of committees 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.
These numbers seem a little low for industry, considering that industry is the major contributor and user of the USP–NF. Industry experts understand what elements are required of a method to optimize analysis and instill confidence that the pharmaceutical material—whether it is the drug substance, excipient, or dosage form—meets the necessary standards of identity, strength, potency, and purity. It is the industry experts who practice the performance of these methods on a daily basis and can understand when a method may not be optimal or suitable for inclusion in the pharmacopeia.
There were nine resolutions proposed for the 2010 Convention—all were adopted. Three were of particular interest to the pharmaceutical industry as outlined herein. The first resolution calls on USP to strengthen its core compendial activities, working collaboratively with industry, regulators,and stakeholders to ensure relevant, timely, and accurate public standards.
This should be USP's foremost activity and focus. The recent recall activities of USP 33–NF 28, along with other issues (e.g., monograph redesign project, the confusing implementation of residual-solvents testing, the number of Errata in the Pharmacopeial Forum) have left industry with a sense that USP is losing touch of its main objective and responsibility to the US pharmaceutical and medical community. The industry relies on USP to provide timely, accurate, and reliable standards. The specifications, methods, and general test procedures published in USP are used by industry to test and release product that is suitable for patient use. During the last five-year cycle, USP expanded operations to India and China and focused a considerable amount of effort on international activities. This growth appears to have stretched USP's resources, which may have potentially contributed to the unprecedented recall of the USP–NF. For USP to regain industry's confidence, the organization must ensure it has the proper amount of resources devoted to monograph standards development.
Second, a resolution on strengthening USP's relationship with the US Food and Drug Administration (Resolution 3) resolves to have USP work more with the agency and other public and private stakeholders 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 seems to supports this resolution and believes it is critical for USP and FDA to work together. However, such a partnership needs to consider the effect of their work on industry as it develops. FDA Commissioner Margaret Hamburg spoke at the convention. She indicated that FDA and USP will be working together to identify materials that should have additional tests to prevent adulteration with the intent of adding these mandatory tests to monographs. It is not readily apparent how adding tests to monographs will actually prevent adulteration. By the time the adulteration is discovered and the potential monograph test is discussed, adopted, and implemented the adulterators have gone on to different adulterants. The best way to stop the adulteration is to the focus on supply-chain knowledge, supplier qualification, and supplier auditing. These activities offer more security regarding the quality of material than does performing an additional monograph test on incoming material receipt.
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.
A complete list of the organizations belonging to USP, the proposed resolutions, and Dr. Hamburg's address are available on the USP website at www.usp.org.
Susan J. Schniepp is president of Schniepp & Associates, a pharmaceutical consulting firm, firstname.lastname@example.org.