2020–2025 Excipients Test Methods Expert Committee Work Plan

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Focus Areas

  • Physical
  • Chemical
  • Performance
  • GMP/GDP/Supplier Qualification/Importation
  • Update/replace existing excipient related test chapters
  • Develop new excipients test procedures
  • Other excipient-related chapters

Expert Committee Charge

  • The Excipients Test Methods Expert Committee is responsible for new excipient related General Chapters development and excipient General Chapters update. It also employs the stakeholder engagement model by collecting information, convening stakeholders, communicating formally and informally (PF, journal articles, Stimuli articles and e-newsletters) and sharing information through educational courses and allowing meeting Observers.

Key Issues

Working with Stakeholders to address the following Key Issues:

  • Collaborating with the Simple and Complex Expert Committees in identifying opportunities to introduce improved analytical tests that add to the existing list of compendial tests
  • Developing and updating General Chapters that help to ensure the quality and functional utility of the pharmaceutical excipients
  • Supporting the update of existing monographs by introducing a wide range of testing required for qualifying an excipient for intended use
  • Developing new test procedures using technologies to measure both the critical quality attributes and material attributes (physical, chemical, microbiological) of excipients to help qualify and measure the quality of excipients, better characterize excipient variability, characterization, and selection of complex excipients (e.g., used in injectable, inhalations, etc.) They would include those that fall outside the monograph specification  
  • Developing information chapters on excipient impurities and composition, and co-processed excipients
  • Expanding on current chapter <1059> Excipient Performance by introducing stand-alone excipient test procedure chapters (above and below 1000 chapters)
  • Developing/updating of above 1000 chapters on excipient GMP, GDP, supply chain and importation practices and Excipient biological safety evaluation

Subgroups and Expert Panels

  • <1059> Excipient Performance Expert Panel
  • Chemical Subcommittee
  • Physical Subcommittee
  • Performance Subcommittee
  • GMP/GDP/Supplier Qualification Subcommittee

Standards Development

  • The latest documentary standard ballot results can be found here (results can be filtered by particular ECs).
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here

Learn more about the impact of this EC and its Associated Expert Bodies