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 Impurities— Limits <232>, Elemental Impurities—Procedures <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.