Standards-Setting Activities of USP's Council of Experts - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Standards-Setting Activities of USP's Council of Experts
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.

Pharmaceutical Technology
Volume 35, Issue 3, pp. 78-88

National Formulary: Excipients Expert Committee

The Excipients Expert Committee concentrates on the development of new monographs and the revision of existing monographs in Pharmacopeial Forum. The Expert Committee also works with both the General Chapters—Physical Analysis and Chemical Analysis Expert Committees in the development of general chapters related to excipients. In addition to monograph content, the Expert Committee is also responsible for approving USP reference standards used in their assigned monographs. Following is a list of key initiatives for the Excipients Expert Committee:

New monograph development. This work is an ongoing effort to establish new standards for excipients in NF.

Monograph modernization. A key initiative in this cycle is modernization of monographs to replace outdated tests or procedures with updated methodology and to add critical quality tests such as identification and impurities. Focus areas include nonspecific identification and assay tests and impurities. USP has identified at least 150 excipient monographs that require modernization. The Expert Committees will collaborate with Expert Committees in other areas (e.g., general chapters), Expert Panels, USP staff, regulators, and stakeholders to outline strategies and implement tactics for monograph modernization.

Monograph redesign. As is the case with monographs published in USP, after the recall of USP 33 -NF 28 most NF monographs remain in the old format. For both USP and NF, the conversion of monographs to the new format will be accomplished during several years, and USP-NF will be the primary publication for the migration of unrevised monographs in the new format. In addition, 149 excipient monographs will be published in the USP Dietary Supplements Compendium Second Supplement.

Harmonization via the Pharmaceopeial Discussion Group (PDG). Harmonize current and future excipient monographs and excipient-related general chapters via the defined work processes of the PDG.

Specific goals for the Excipients Expert Committee during this cycle include:

  • Update the USP-NF Monograph Submission Guideline to include coprocessed excipients and to clarify the minimum criteria for monograph sponsors who wish to submit requests for revision to NF.
  • Collaborate with the Expert Panels associated with the General Chapters—Physical Analysis and Chemical Analysis Expert Committees on the revision of Ex-cipient Performance <1059>, development of general information chapter Good Distribution Practices for Bulk Pharmaceutical Excipients <1197>, and updating general chapters dealing with rheology and material characterization.
  • Work with the Chemical Analysis and Physical Analysis Expert Committees to develop a guidance chapter on economically motivated adulteration.
  • Continue collaborative efforts to harmonize excipient monographs and excipient-related general chapters by work with PDG.
  • Work with USP's standards acquisition group to identify and work with sponsors in the procurement of monographs that are not currently in NF but are listed in FDA's Inactive Ingredients Database.

Food Chemicals Codex: Food Ingredients Expert Committee

The charge of the Food Ingredients Expert Committee is to increase the number of monographs for food ingredients together with their associated USP reference standards, to develop relevant chapters about general tests and assays, and to modernize and revise all existing monographs and general tests and assays in Food Chemicals codex (FCC). All text in FCC is authorized (in distinction to official text, which is enforceable by regulators). FCC is recognized to various degrees as legally binding by the governments of the United States, Canada, Australia, New Zealand, Israel, and others.

The workplan of the Food Ingredient Expert Committee for the 2010-2015 cycle includes the following:

  • Identify, prioritize, and develop monographs for nationally and internationally approved food ingredients, food additives, colorants, and others via interactions with FDA and other governmental organizations (national and international), innovators, associations, and interested stakeholders.
  • Continue to monitor published research for new toxicology and other data and evaluate the need to revise or modernize existing monographs.
  • Monitor technological developments and prioritize the modernization of test methods in monographs and general tests and assays, taking into account the international reach of FCC and the variable rate at which different regions can adapt to new technologies.
  • Work with the Toxicology Expert Committee to prioritize development of monographs for food ingredients that enjoy only self-affirmed generally recognized as safe status.
  • Develop monographs and general tests and assays for probiotics and prebiotics in collaboration with the Microbiology Expert Committee.
  • Develop further additions to the informational chapters on microbiological methods, methods to test authenticity, and tests for specific contaminants—these may be helpful to analysts and decision makers but are not a mandatory part of the monograph.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

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.
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.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here