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Rapid Microbiology Methods: A Regulatory Perspective

Learn about FDA experiences, release tests, microbial limits, and more in the context of rapid microbiology methods. Understand validation, concerns, and initiatives for better practices. Discover the shift towards faster, sensitive methods.

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Rapid Microbiology Methods: A Regulatory Perspective

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  1. Rapid Microbiology Methods A Regulatory Viewpoint Bryan S. Riley, Ph.D. U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmaceutical Science PDA Sterile Manufacturing Practices in the Third Millennium: A Regulatory and Industry Perspective Milan, Italy 23 - 25 June 2003

  2. FDA Experience • Release Tests • Microbial Limits • Sterility • Other • Water • Bioburden • Environmental Monitoring Bryan S. Riley, Ph.D.

  3. Micro Methods Overview • Traditional Methods (plate counts, mpn) • simple • inexpensive • accepted • Rapid Methods • fast • sensitive Bryan S. Riley, Ph.D.

  4. FDA Concerns • Increased Sensitivity of Rapid Methods • changing (raising?) microbial limits acceptance criteria • Sterility Test “False Positives” • clear criteria for invalidation of test result Bryan S. Riley, Ph.D.

  5. Validation • Test Organisms • Compendial Organisms • Environmental Isolates • Sample Specific Issues • Inhibition/Interference • Parallel Testing Bryan S. Riley, Ph.D.

  6. Validation • Equivalent or Better? • Guidance • PDA Technical Report 33 - Evaluation, Validation and Implementation of New Microbiological Testing Methods • USP Draft Chapter <1223> - Validation of Alternative Microbiological Methods Bryan S. Riley, Ph.D.

  7. FDA Initiatives • Process Analytical Technology (PAT) • Includes rapid micro • Microbiology Subcommittee for ACPS • GMP’s for the 21st Century • Product specialists for inspections • Dispute resolution process at Center level Bryan S. Riley, Ph.D.

  8. Summary • Rapid Methods vs. Traditional Methods • Is there a comparison? • Apprehension by Industry • Why? Bryan S. Riley, Ph.D.

  9. What Next? • Meet with CDER Microbiologists • Validation issues • Filing requirements • Submit applications containing rapid microbiology methods Bryan S. Riley, Ph.D.

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