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

Chemical Analysis Expert Committee. The charge of the General Chapters—Chemical Analysis Expert Committee is to revise and create general chapters that provide standards and guidance to help USP-NF users when a chemical analysis is performed. This Expert Committee is responsible for more than 80 general chapters, including those involving spectroscopy, chromatography, and metals analysis. In addition, this Expert Committee handles general chapters related to dietary supplements. Some of the key initiatives for this group include:

  • Continuing USP's elemental impurities initiative, leading to final versions of general chapters Elemental ImpuritiesLimits <232>, Elemental ImpuritiesProcedures <233>, and Elemental Impurities in Dietary Supplements <2232>
  • Finalizing the nuclear magnetic resonance required and informational general chapters <761> and <1761> and using these as templates to update the other existing spectroscopy chapters and to develop a series of new ones
  • Harmonizing the USP general chapter Chromatography <621> with the European and Japanese pharmacopoeias, with an allied and continuing effort to enable new technologies without the need to update the chapter
  • Providing chemistry, spectroscopy, and chromatography expertise to the dietary supplements general chapters to strengthen and broaden USP's efforts in this area.

Physical Analysis Expert Committee. The charge of the General Chapters—Physical Analysis Expert Committee is to initiate and develop general chapters that help users of USP-NF when a physical analysis is performed. This Expert Committee supports, updates, and develops general chapters concerned with physical characterization of excipients and drug substances general chapters that provide standards and guidelines for users concerned with regulatory sciences. Plans for the current cycle include:

  • Updating guideline chapters concerned with the regulatory sciences (e.g., Verification of Compendial Procedures <1226>)
  • Development and updating of general chapters dealing with excipient performance (<1059>), excipient-distribu-tion practices, rheology, and material characterization
  • Updating Weights and Balances <41> and its accompanying informational general chapter <1251>.

Biological Analysis Expert Committee. The charge of the General Chapters—Biological Analysis Expert Committee is to initiate and develop documentary standards when a biological analysis is performed. This Expert Committee also reviews and approves reference standards used in a particular chapter. In this cycle, the committee will focus on product class general chapters for biologics. Biological products can be divided into different molecular classes based on their structure and function (e.g., polypeptides including proteins and peptides, enzymes, glycosaminoglycans, im-munoglobulins, and others). For many of these molecule classes, established platform approaches exist in terms of manufacturing, regulatory expectations (often reflected in FDA guidance to industry), and consequently, analytical characterization and quality control.

Approaching characterization and control by product class as much as possible affords important advantages: It gives the opportunity to establish and define acceptable assay approaches in important areas like potency determination, detection of common process impurities, or characterization of known, class-specific post-translational modifications. These approaches in turn are linked to general and public (compendial) procedures that do not rely on a single manufacturer's experience. These procedures then clearly establish the baseline for what is analytically acceptable. The class approach helps define and establish critical quality attributes that are common to a class of molecules rather than an individual product and hence can help focus and delineate scientific discussions around product identity and uniqueness.


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