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

Monograph redesign. As a result of the recall of USP 33-NF 28, most of the monographs remain in the old format. The conversion of monographs to the new format is expected to be complete by the close of the revision cycle (2015). Beginning with USP 35-NF 30, each annual edition will introduce a portion of the monographs (those without revisions) in the new format. USP 33-NF 28will be the primary publication for the migration of unrevised monographs in the new format. All new USP and pending monographs, revision proposals, and accelerated revisions will be published in the new format (11).

Expert Committee goals for this cycle include:

Chemical Molecules 1. Explore options for converting micro-bial assays to high-performance liquid chromatography (HPLC).

Chemical Molecules 2. Develop strategies for OTC monograph modernization and new monograph development. Although each of the four Expert Committees has monographs for OTC drugs and products, the majority are with Chemical Molecules 2, so USP anticipates that this Expert Committee will be a focal point.

Chemical Molecules 3. Collaborate with the Expert Panel associated with the Dosage Forms Expert Committee on the solubility criteria for veterinary drugs.

Chemical Molecules 4. Collaborate with the Expert Panel associated with the General Chapters—Physical Analysis Expert Committee on the revision of Radiopharmaceuticals for Positron Emission TomographyCompounding <823>.

Biological expert committees. Two Expert Committees focus on monographs for biological medicines, including those arising from recombinant technologies. These Expert Committees concentrate on the development of new monographs and the revision of existing monographs. Both Expert Committees will support biosimilar biologics through monographs and also through general chapters, working with the General Chapters—Biological Analysis Expert Committee.

Biologics and Biotechnology—Monograph Committee 1. This Expert Committee develops and revises monographs for peptide, protein, glycoprotein, glycosaminoglycan therapeutics, and monoclonal antibodies. The Expert Committee sponsors several Expert Panels on unfractionated and low molecular weight heparins, as well as on therapeutic enzyme preparations. The Unfractionated Heparin Expert Panel currently is working in close collaboration with FDA on the stage-3 revision of the heparin sodium monograph. The low molecular weight heparin panel is addressing both monographs and procedural chapters for this class of therapeutic product. The Therapeutic Enzyme Expert Panel will continue to address the modernization of monographs for pancreatic enzyme products as well as enzymes in several other therapeutic areas. The Expert Committee is also cosponsoring an Expert Panel that will develop the chapter, Quality Attributes of Therapeutic Monoclonal Antibodies <129>.

Biologics and Biotechnology—Monograph Committee 2. This Expert Committee develops and revises monographs for a diverse area of biological products that include plasma-derived blood products, vaccines, and gene, cell, and tissue therapies. An Expert Panel has already been formed to address tissue-based products, an area of growing importance in the portfolio of this committee. Modernization and expansion efforts also will be devoted to the area of blood coagulation factors for which a second Expert Panel will initially focus on a monograph for plasma-derived Factor IX. Because of the challenge of developing full-length vaccine monographs, the Expert Committee hopes to collaborate with the General Chapters—Biological Analysis Expert Committee to explore the concept of class chapters for vaccines.

General chapters expert committees

Several Expert Committees are dedicated to the development and maintenance of the nearly 250 general chapters in USP-NF. The general chapters have been written over many years and by many different Expert Committees.

Each chapter's style, information content, and state of the art depends in part on when it was last updated. Goals for this cycle spanning all the general chapters' committees include:

  • Establishing a format for procedural chapters, standardizing the format and level of information for these chapters.
  • For chapters covering similar technologies (e.g., spec-troscopy), developing consistent formats for required and informational chapters to standardize information content and to make them easier both to understand and to write.
  • Developing product quality, product performance, and biologics product class chapters that are supported by informational chapters providing general guidelines and procedures with, where practical, acceptance criteria and supporting reference standards. These will help establish the verification of a compendial procedure and the acceptability of alternative procedures.
  • Developing consistent messages to each Expert Committee establishing expectations for cross-committee collaboration and establishing the primary customers for general chapters (i.e., analysts, regulators, and regulatory scientists).


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