Monographs and reference standards
Sessions in this track began with the US perspective on counterfeiting. USP has promoted the public availability of documentary
standards and reference standards as first-line tools in the fight against counterfeit and substandard medications. Although
US patients enjoy generally good quality medicines, FDA has received reports that certain so-called lifestyle drugs—or their
polymorphs—have been mixed with dietary supplements. The rise of mail-order pharmacies and online medication ordering increase
public exposure to medicines that may have been adulterated during passage through distribution markets, which adumbrates
USP's call for public standards, including attention to its standards for packaging, storage, and distribution.
Another session in this track addressed uncertainty in reference standards—an important topic as USP moves forward with its
plans to offer certified reference materials (CRMs). USP plans to determine the uncertainty of reference materials by applying
rigorous metrological approaches and by including a certificate with the resulting CRM that states this uncertainty. The methodological
rigor of this program is demanding but also rewarding. It quantifies and reports error, allowing customers who follow International
Organization for Standardization (ISO) 17025 to calculate their uncertainty budgets more precisely.
The final session in this track addressed excipients and noted gaps in industry's treatment and understanding of excipients,
including the General Notice requirements, the need to update analytical procedures, gaps between formulation scientists' understanding of excipient composition
and performance, and the lack of sufficient control of the excipient supply chain. Updates to NF and FCC monographs are underway, and USP is working with the International Pharmaceutical Excipient Council and other stakeholders
to promote excipient quality and standards.
General Chapters and performance testing
This track focused on the performance verification test (PVT), which supports horizontal, or international, standards because
it is based on interlaboratory collaborative studies that are conducted according to guidances from ISO, and national metrology
laboratories. For dissolution testing, USP has proposed moving from an apparatus or basket-based approach to an assembly-based
approach that comprises six or eight apparatus. In this manner, USP encourages industry to test samples in assemblies—not
individual dosage forms—thereby identifying unacceptable batches rather than unusual samples. The overall goal is to apply
current metrologic approaches to PVT as part of a robust attempt to reduce both manufacturer risk (unnecessarily failed batches)
and consumer risk (substandard batches released into commerce).
Biologics and biotechnology
The third track discussed bioassays. A bioassay should be based on data that lead to a model of the system under study, thereby
generating information about the model system, and in turn leading to a decision about manipulating the system, with subsequent
action in the laboratory or clinic. To design a bioassay, one reverses the process, but bioassay design often is complicated
by a large number of variables and potential misunderstandings about the goal of the process. A bioassay specification is
not necessarily a product specification, although the former contributes to the development of the latter.
USP is actively involved in revising existing General Chapters such as "Design and Analysis of Biological Assays" <111> and
is developing many new General Chapters to assist biopharmaceutical practitioners. The overall goal of the USP Biologics and
Biotechnology group is to develop procedural and performance standards that will enable biopharmaceutical scientists to characterize,
develop, market, and control products with a high degree of certainty that these products maintain their quality attributes.
The 2007 USP Annual Scientific Meeting was notable for the large amount of information shared both in structured podium sessions
and during informal exchanges. Looking ahead, USP plans to continue to develop and adapt its meeting format in the service
of fostering the exchange of information that will promote the development of stronger international standards and good pharmaceutical
To view meeting updates for the United States Pharmacopeia, visit
To view the 2007 USP Annual Scientific Meeting schedule, visit
Roger L. Williams, MD, is executive vice-president and chief executive officer, and Darrell R. Abernethy, MD, PhD,* is chief science officer at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8141, firstname.lastname@example.org
Dr. Williams is a member of Pharmaceutical Technology's Editorial Advisory Board. The authors thank Stefan Schuber, PhD, director of scientific reports at USP, for editorial assistance.
*To whom correspondence should be addressed.