2020–2025 General Chapters - Dosage Forms Expert Committee Work Plan

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Focus Areas

  • Guidance for dosage form definitions and product quality attributes, and dosage forms in vitro performance testing

Expert Committee Charge

  • The General Chapters–Dosage Forms Expert Committee is responsible for developing new and revising existing general chapters related to pharmaceutical dosage forms.

Key Issues

  • Exploring performance verification tests for dissolution apparatus
  • Product Quality Tests

Subgroups and Expert Panels

  • Pharmaceutical dosage forms definitions and critical quality attributes
  • Performance testing
  • Rheology
  • Disintegration and Dissolution
  • Particulate matter determination
  • Uniformity of dosage units
  • Nanotechnology

Standards Development

  • The latest 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.

Contact

  • Margareth R. C. Marques, Ph. D., Principal Scientific Liaison - General Chapters, mrm@usp.org
  • Allison von Berg, M.F.S., J.D., Expert Committee Manager, abv@usp.org