Modernization of monograph and general chapter standards will continue to be a top priority for the US Pharmacopeial Convention
(USP) in 2013. USP also will continue to develop and revise general chapters that have broad impact on multiple monographs
appearing in all its compendial publications—United States Pharmacopeia and the National Formulary (USP–NF), Food Chemicals Codex, Medicines Compendium, Dietary Supplements Compendium, USP on Compounding, and Herbal Medicines Compendium. Modernization priorities have also factored into the expansion of laboratory capabilities at USP's international sites in
Brazil, China, and India as well as its headquarters in Rockville, Maryland. These enhanced capabilities will support USP's
in-house reference standard development efforts.
Anthony J. DeStefano
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In the area of identification tests, USP is increasingly resorting to the use of instrumental tests as alternatives to older,
less-specific tests. USP's Chemical Analysis Expert Committee has made the modernization of General Chapter <191> Identification
Tests—General a high priority during USP's 2010–2015 cycle, particularly in light of the general chapter's direct relevance
to hundreds of monographs in USP–NF, many of which are themselves currently being modernized. Much of the Expert Committee's work will be based on feedback from
a manufacturer survey conducted by USP in 2011 in which 92% of the respondents reported using traditional wet chemistry tests
for identification. Within that group, 64% also reported using additional instrumental testing methods that are more specific—an
indicator for a need to modernize this test for the identity of a material sample (1).
Validation and verification in quality control
For manufacturers, validation and verification of analytical procedures play important roles in quality control activities
in the laboratory. USP has established an Expert Panel that will propose revisions to the three USP General Chapters: <1224>
Transfer of Analytical Procedures; <1225> Validation of Compendial Procedures; and <1226> Verification of Compendial Procedures.
While USP–NF specifies that only results obtained by methods and procedures in the compendia are deemed conclusive, USP–NF does provide guidance in General Chapter <1225> on validating non-compendial procedures for those who wish to use alternative
methods for conformity assessment. In General Chapter <1226>, USP–NF provides guidance on verification—a user's demonstration that an article is suitable to be analyzed by methods and procedures
described in the compendia. Overall, USP also is evaluating more closely the statistical approaches applied to validation
and verification that would enable manufacturers to predict that their procedures will be fit-for-purpose.
Good distribution practices
Another major area of activity in 2013 for USP's General Chapters will be the development of a suite of general chapters relating
to supply-chain issues. In 2012, USP hosted a public workshop for manufacturers, practitioners, regulators, and other stakeholders
to obtain feedback on an initial proposal for an informational USP general chapter titled <1083> Supply Chain Integrity. The
purpose of the general chapter was to provide a resource for all parties, regardless of size and role in the global supply
chain, for the production, distribution, and delivery of medicines to patients. In a planned new approach, USP will evaluate
all the available good distribution practices for drug products, drug substances, excipients, dietary supplements, compounded
preparations, and other subcategories of compendial articles. It is hoped that this will enable USP to develop a new structure
for good distribution practices that will encompass informational general chapters relating to quality management systems,
environmental control management, importation and exportation, and supply chain integrity.
Anthony J. DeStefano, PhD, is senior vice-president, general chapters and healthcare quality standards at the United States Pharmacopeial Convention.
1. USP, "2011 USP Identification Testing Methods Survey" (USP, 2011).