2020-2025 General Chapters - Microbiology Expert Committee Work Plan

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Focus Areas

  • Nonsterile Products
  • Endotoxins and Pyrogens
  • Microbiological Control of Cell and Gene Therapy Products
  • Sterility Assurance
  • Modern Microbiological Methods
  • Sterilization and Aseptic Processing

Expert Committee Charge

  • The General Chapters–Microbiology Expert Committee is responsible for developing new and revising existing general chapters related to microbiology and sterility assurance. The Expert Committee also evaluates sterility assurance, bacterial endotoxins, and microbial quality requirements for particular monographs.

Key Issues

  • Developing and updating USP–NF standards for microbiological quality of both nonsterile and sterile products, including pharmaceuticals, biologics, compounding, and dietary supplements -. This includes guidance on bioburden and endotoxin control, sterilization and sterility assurance, control and monitoring of aseptic processing environments, microbiological control of cell and gene therapy products and modern microbiological methods - that help assure, where needed, sterile, and microbiologically safe articles
  • Providing guidance to other Expert Committees and Expert Panels on issues relating to microbiology and sterility assurance

Associated Expert Bodies

  • Definitions
  • Microbiological Quality of Nonsterile Products
  • Bacterial endotoxins
  • Depyrogenation
  • Sterilization
  • Sterility assurance
  • Package Integrity Testing
  • Modern Microbiological Methods

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

  • Radhakrishna Tirumalai, Ph.D., Principal Scientific Liaison - General Chapters, rst@usp.org
  • Nicole Addy, Expert Committee Manager, Nicole.addy@usp.org