2015–2020 Excipient Monographs 2 Expert Committee Work Plan


  • Catherine Sheehan, Ph.D., Senior Director - Excipients, cxs@usp.org

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Focus Areas

  • International harmonization
    • Pharmacopeial Discussion Group (PDG)
    • Bilateral Harmonization
    • Prospective harmonization of API, DP, and Excipients
  • Monograph modernization with associated RS
  • New monograph development with associated RS
  • New excipient related chapters development
  • Excipient General Chapters update

Expert Committee Charge

  • The Excipient Monographs 2 Expert Committee is responsible for global harmonization activities that include: retrospective harmonization of excipient monographs, excipient related General Chapters for the PDG work plan and works closely with other Expert Committees (GCCA, GCPA, B&B) on General Chapters, B&B General Chapters and ICH Q6A chapters. The committee is also responsible for developing new and revising existing excipient monographs, their associated reference standards for pharmaceutical excipients and for new excipient-related General Chapters development and updates. The EC works with global pharmacopeias on bilateral harmonization and is also responsible for prospective harmonization of API, DP and excipients. Excipient Monographs 1 and 2 Expert Committees collaborate through the Excipient Monograph Collaborative EC and with other collaborative ECs.

Key Issues

  • Global Harmonization:
    • PDG support and collaboration with other pharmacopeias in updating and harmonizing high priority excipients in the global market
    • Bilateral Harmonization
    • Prospective Harmonization of API, DP, and Excipients
  • Priority Monograph Modernization Initiative
    • Identify gaps in current excipient monograph specifications to assure fit for purpose in a global supply chain setting
  • Development of missing excipient monographs and Associated RSs
  • Development of excipient-related General Chapters and update of existing General Chapters to reassure the user that an excipient is fit for purpose

Subcommittees and Expert Panels

  • Subcommittee D (Cellulosics)
  • Subcommittee E (Inorganic Minerals)
  • Subcommittee F (Organic Small Molecules)
  • Subcommittee G (Povidones)
  • Subcommittee H (Starches)
  • Subcommittee I (Sweeteners)
  • Subcommittee J (Water)
  • Subcommittee K (Waxes/Polymers/Stearates)
  • <1195> Significant Change Guide For Bulk Pharmaceutical Excipients Joint Subcommittee
  • Co-processed Excipients Joint Subcommittee
  • Element Specific Chapters Joint Subcommittee
  • Metal Impurities Joint Subcommittee
  • General Chapters - PDG Joint Subcommittee
  • Impurities Joint Subcommittee
  • Lactoses Joint Subcommittee
  • Polyethylene Glycol Joint Subcommittee
  • Polysorbates Joint Subcommittee
  • Bilateral Harmonization Subcommittee
  • Prospective Harmonization Subcommittee
  • Excipients/Dietary Supplement/Foods/Herbal Medicines Joint Standards-Setting Subcommittee (JS3)
  • Glycerin Expert Panel
  • Talc Methods Expert Panel

Ballot Results and Standards Development