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. 

Key Issues

  • Develop and update General Chapters that help to ensure the quality and functional utility of the pharmaceutical excipients 
  • Support the update of existing monographs by introducing a wide range of testing required for qualifying an excipient for intended use.
  • Develop 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  
  • Develop information chapters on excipient impurities and composition, and co-processed excipients
  • Expand on current chapter <1059> Excipient Performance by introducing stand-alone excipient test procedure chapters (above and below 1000 chapters)
  • Development/update of above 1000 chapters on excipient GMP, GDP, supply chain and importation practices

Subgroups and Expert Panels

  • TBD

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

Articles

Contact

  • Catherine Sheehan, DRSc, MS., MS., Senior Director - Excipients, cxs@usp.org
  • Nicole Addy, Expert Committee Manager- Excipients, Nicole.addy@usp.org