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Rapid Microbiology Methods A Regulatory Viewpoint

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

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Rapid Microbiology Methods A Regulatory Viewpoint

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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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