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

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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

Statistics Expert Committee

The charge of the Statistics Expert Committee is to initiate and develop general chapters to help USP-NF users with statistical treatment of data in support of USP's documentary and reference material standards. This Expert Committee provides support to other Expert Committees regarding statistics and biostatistics. The Statistics Expert Committee is:

  • Developing a series of chapters on the statistical aspects of biological assay method development and design (<1032>), validation (<1033>), and analysis (<1034>)
  • Working with the Chemical Analysis and Physical Analysis Expert Committee to update and supplement the general chapters related to validation (e.g., <1225>) and verification (e.g., <1226>)
  • Playing a key role in the development of a proposed new chapter on the use of chemometrics, continuing the work of prior cycles
  • Develop a new general chapter to address statistical issues in method comparison and method transfer.

Toxicology Expert Committee

The Toxicology Expert Committee develops and revises general chapters in which toxicology plays a pivotal role, including biocompatibility. This Expert Committee will provide toxicology support to other committees in, among others, metal toxicity, genotoxic impurities, extractables and leachables, and residual solvents. The committee will lead the revision of general chapters Biological Reactivity Tests, In Vitro <87>, Biological Reactivity Tests, In Vivo <88>, and Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants <1031>. The committee will also provide toxicology support for committees dealing with food, dietary supplement, and excipient issues.

USP Reference Standards

The charge of the Reference Standards Expert Committee is to guide the policy and processes by which USP tests, characterizes, assigns value to, packages, and releases reference materials for monographs in all of USP's compendia. The Expert Committee members provide guidance about related topics such as harmonization, continuing suitability for use, and metrological principles related to the development of reference materials (2).

Reference Standards Expert Committee. The work plan of the Reference Standards Expert Committee includes the following (note that many of these activities will be accompanied by an explanatory Stimuli article in USP's online journal of standards development, Pharmacopeial Forum ( http://www.usp. org/USPNF/pf/):

  • Review the experimental design for USP collaborative testing (with Stimuli article)
  • Develop a general information chapter on reference materials incorporating information and guidance from the International Organization for Standardization, the Bureau International des Poids et Mesures, the International Conference on Harmonization, and others as appropriate
  • Develop recommendations for developing biological reference standards (with Stimuli article)
  • Make recommendations for harmonization of reference materials (with Stimuli article)
  • Publish recommendations for a stability program for USP reference materials
  • Develop recommendations for expiry dating of pharma-copeial reference materials (with Stimuli article)
  • Review the metrological principles involved in the development of USP reference standards
  • Periodically review the reference standard approval process
  • Periodically review reference standard candidates and make recommendations on their use and release
  • Review USP procedures that relate to reference standard operations.


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