2015–2020 General Chapters - Microbiology Expert Committee Work Plan


  • Radhakrishna Tirumalai, Ph.D., Principal Scientific Liaison - General Chapters, rst@usp.org

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Past Meetings – Executive Summaries

Focus Areas

  • Depyrogenation
  • 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, dietary supplements and food ingredients. This includes guidance on bioburden control, sterilization and sterility assurance, control and monitoring of aseptic processing environments and FCC standards 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

Subgroups and Expert Panels

  • Bacterial endotoxins
  • Depyrogenation
  • Sterilization
  • Sterility assurance
  • Microbiological Methods

Ballot Results and Standards Development