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Focus Areas
- Endotoxins and Pyrogens
- Rapid Microbial Methods
- Nonsterile Products
- Microbiological Control of Cell and Gene Therapy Products
- Sterility Assurance
- 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 compendial monographs, as appropriate.
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 rapid microbial 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
- Endotoxins and Pyrogens
- Rapid Microbial Methods
- Sterility assurance & Microbial Control
- Definitions
- Bioburden and Contamination
- Microbiological Issues in Dietary Supplements and Food Ingredients
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
- Huiping Tu, Ph.D., Senior Principal Scientist – Science-General Chapters, hpt@usp.org
- Kimberly McKinney, MBA, Expert Committee Manager, kam@usp.org