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Compliance Update Allergenic Products Advisory Committee Meeting March 5, 2001

Compliance Update Allergenic Products Advisory Committee Meeting March 5, 2001. Mary Malarkey Director, DCM/OCBQ Center for Biologics Evaluation and Research. Enforcement Actions Biological Product Deviation Reports formerly Errors and Accidents Recalls

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Compliance Update Allergenic Products Advisory Committee Meeting March 5, 2001

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  1. Compliance UpdateAllergenic Products Advisory Committee Meeting March 5, 2001 Mary Malarkey Director, DCM/OCBQ Center for Biologics Evaluation and Research

  2. Enforcement Actions • Biological Product Deviation Reports • formerly Errors and Accidents • Recalls • Issues Leading to Enforcement Actions • Forward Thinking

  3. Enforcement Actions • Seizures • Injunctions • Warning Letters • License Suspension • License Revocation - NOIR • Other • Letter after NOIR • Regulatory Meeting with Agency

  4. Enforcement ActionsAllergenic Product Manufacturers

  5. Inspection vs. Enforcement FY99

  6. Inspection vs. Enforcement FY00

  7. FY01 Enforcement Actions • If inspection in FY00, but action taken in FY01, inspection counted for FY01 • Other inspections completed in FY01 pending classification or review • NAI - No Action Indicated • VAI - Voluntary Action Indicated • OAI - Official Action Indicated - warrant further review

  8. Inspection vs. Enforcement FY01

  9. Biological Product Deviations • 21 CFR 600.14 • Final rule effective July 6, 2001 • most firms adopting currently • problems with product in distribution • Examples - Precipitates, stability failures

  10. Biologic Product Deviation Reports

  11. Precipitates • Accounts for high numbers of BPDs for Allergenic Products • Reports may be combined as long as 45 day reporting requirement met • Issue discussed between APMA and CBER in October 2000 • Interim measures in effect

  12. Recalls • Voluntary on part of manufacturer • Allergenics - related to sterility

  13. Allergenic Product Recalls

  14. Most Frequent Issues ® Enforcement Actions -1999-2001 • Inadequate Investigations and CAPA • failures during production and testing • complaint handling • precipitates (interim plan) • Refiltration/Reprocessing/Reworking • lack of validation • sterility assurance concerns

  15. Continued... • Container/Closure • integrity • processing • Validation • processes, systems, assays • equipment qualification • Reserve samples; inspection • 211.170

  16. Continued…. • Biological Product Deviation Reporting • includes stability failures • SOPs Deficiencies • Annual Review

  17. Improvement Noted • Container Closure Integrity • SOPs • in place; still need tweaking • Validation • all areas including refiltration, etc. • Annual Reviews and Retention Samples • BPDR reporting • but still an issue when precipitates not cause

  18. Forward Thinking • Precipitate issue • continue work between manufacturers and CBER with goal of understanding and preventing • may be reported (BPDs) en masse; provided time frame met.

  19. Forward Thinking ..cont... • Sterility Test Regulation (21 CFR 610.12) • Recognized as outdated with respect to current expectations • automatic retest, and repeat retest • lack of investigation • Discussions ongoing to revise or eliminate 610.12(b) • Policy will be documented prior to regulation change

  20. Further Information • CBER Home Page • www.fda.gov/cber • BPD Final Rule • www.fda.gov/cber/biodev/biodev.htm • Division of Case Management • 301-827-6201

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