2015–2020 General Chapters - Microbiology Expert Committee Work Plan

Contact

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

Interested in learning more about the work of this Expert Committee?

Download Roster Observe a Meeting

Upcoming Official Meetings

  • October 25, 2017 face-to-face meeting at USP–U.S., Rockville

Past Meetings – Executive Summaries

Latest Updates

  • October 25, 2017 face-to-face meeting at USP–U.S., Rockville

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