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AR egulatory View of Rapid Microbiology Methods by gPkUS1r7

VIEWS: 7 PAGES: 9

									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
                    FDA Experience
• Release Tests
     – Microbial Limits
     – Sterility
• Other
     – Water
     – Bioburden
     – Environmental Monitoring

23 - 25 June 2003       Bryan S. Riley, Ph.D.   2
        Micro Methods Overview
• Traditional Methods (plate counts, mpn)
     – simple
     – inexpensive
     – accepted
• Rapid Methods
     – fast
     – sensitive

23 - 25 June 2003    Bryan S. Riley, Ph.D.   3
                    FDA Concerns
• Increased Sensitivity of Rapid Methods
     – changing (raising?) microbial limits acceptance
       criteria
• Sterility Test “False Positives”
     – clear criteria for invalidation of test result




23 - 25 June 2003       Bryan S. Riley, Ph.D.            4
                    Validation
• Test Organisms
     – Compendial Organisms
     – Environmental Isolates
• Sample Specific Issues
     – Inhibition/Interference
     – Parallel Testing


23 - 25 June 2003     Bryan S. Riley, Ph.D.   5
                    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


23 - 25 June 2003    Bryan S. Riley, Ph.D.        6
                    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


23 - 25 June 2003       Bryan S. Riley, Ph.D.       7
                    Summary
• Rapid Methods vs. Traditional Methods
     – Is there a comparison?
• Apprehension by Industry
     – Why?




23 - 25 June 2003     Bryan S. Riley, Ph.D.   8
                    What Next?
• Meet with CDER Microbiologists
     – Validation issues
     – Filing requirements
• Submit applications containing rapid
  microbiology methods



23 - 25 June 2003     Bryan S. Riley, Ph.D.   9

								
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