Modernization of USP Standards - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Modernization of USP Standards
The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.


Pharmaceutical Technology
Volume 37, Issue 2


Anthony J. DeStefano
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.

Identification tests

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.

Reference

1. USP, "2011 USP Identification Testing Methods Survey" (USP, 2011).

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
28%
Oversee medical treatment of patients in the US.
9%
Provide treatment for patients globally.
9%
All of the above.
41%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here