Microbiological Control of Compendial Articles: A Workshop on Current Status and Future Directions of Compendial Standards
USP's role in microbiological control is to develop public standards pertaining to microbiological quality, including sterility assurance, that, along with other requirements, ensure the consistent quality of products—dosage forms, excipients, drug substances, food ingredients, and dietary supplements.
The workshop will present information on current USP Microbiology Expert Committee chapters and potential and draft chapters in the areas of bioburden control of nonsterile products, sterilization and sterility assurance, validation of alternate microbiological methods, and rapid/modern microbiological methods. The breakout sessions will solicit discussion and input from stakeholders.
- Provide an overview of recent and current work of the USP General Chapters Microbiology Expert Committee vis-a-vis new and revised chapters and chapter proposals in order to solicit feedback on the committee’s current and future standards-setting activities
- Foster conversation that focuses on better understanding the needs of stakeholders
- Microbiology laboratory supervisors and microbiologists
- Contract microbiology laboratory staff responsible for testing pharmaceuticals, biologics, dietary supplements, food ingredients, and medical device products
- Regulatory QA, QC, and compliance personnel