USP's role in supply-chain integrity
There has been much discussion in the industry regarding the challenges posed by a global supply chain, and yet, there are
no overarching, comprehensive industry-wide practices to date. What does exist is piecemeal, with pockets of information available
through FDA guidance, trade organizations, and other sources. USP believes it can provide value as a convener of different
stakeholders. The organization can bring disparate views together and help organize the prevailing thoughts, finding commonalities
among all players. In addition, through its inclusion in USP–NF—compendia widely recognized both domestically and internationally—recommendations put forth in a general chapter can have
more weight than, for example, a technical report.
Finally, with USP–NF in a continuous state of revision, a mechanism exists for consistently updating the recommendations to reflect current realities.
Because change is constant, USP's Expert Committee will be charged with monitoring whether there is a need for adapting the
general chapter, thereby providing all parties with one central place for up-to-date information.
Given the complexity of this topic, USP is seeking extensive input from all the parties that have an interest in the new general
chapter <1083>. Although the expert committee responsible for the chapter represents a diverse group of manufacturers, pharmacists,
and other experts, USP is seeking additional perspectives to assist in providing a strong final product. The draft general
chapter being published this spring may be deemed too broad or too specific, or may evolve into multiple chapters, for instance.
USP will evaluate all of these considerations based on feedback received from the diverse stakeholder community. In addition
to comments obtained via the PF, USP is planning a Supply Chain Integrity Workshop at its headquarters in Rockville, MD, on May 22-23, 2012, to further solicit
input. The workshop will seek to clarify USP's role in supply-chain integrity and address key topics such as related regulation
and technology, and the roles and responsibilities of all parties in the supply chain. The workshop will have a strong international
component as well.
Anthony DeStefano, PhD, is vice-president of general chapters, and Desmond Hunt, PhD, is a senior scientific liaison, both at the US Pharmacopeial Convention (USP).