Efforts to Ensure Excipient Safety - PowerPoint PPT Presentation

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Efforts to Ensure Excipient Safety

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  1. Efforts to Ensure Excipient Safety FDA Economically Motivated Adulteration Conference 19

  2. Excipient Industry Efforts to Stop EMA • Develop trust in your excipient supplier BUT verify • IPEA Excipient Audit Program • IPEA Excipient Certification Program • Conformance to Good Manufacturing Practices (GMP) • Conformance to Good Distribution Practices (GDP) • Improve supply chain integrity • Confirm Excipient Pedigree • Enhance excipient receipt and approval • The pharmaceutical company has ultimate responsibility for excipient suitability! 19

  3. Supplier Qualification • Direct from Manufacturer • Assess Manufacturer • Purchased from Distributor • Must know manufacturer and site • Must know role of distributor • Warehousing • Packaging • Repackager • Assess Distributor and Manufacturer 19

  4. Supplier Qualification • Ideal: Pharmaceutical Manufacturers audit all excipient suppliers • Impact: Each audit cycle • Pharmaceutical Manufacturer • Hundreds to thousands of sites to audit globally • Pfizer reported 4,000 suppliers after mergers • Excipient Supplier (ISP) • Host over 300 site audits at Texas City facility! • Unsuitable: Questionnaire/paper audit! 19

  5. Excipient Audit Program • Objective: Substitute IPEA audit for Pharmaceutical manufacturer audit • Goal: Reduce audit cost through report sharing • Program: • 1-Day audit by qualified auditors • Quality review of report by IPEA Executive • Report available for 2 years 19

  6. Excipient Certification Program • Accredit to American National Standards Institute • Develop Auditable Standard • Document Certification Program • Create Program Administration • Establish Objective Expectations • Create Certification Body • Prepare Quality Manual • Host ANSI Assessment 19

  7. Standards Action Standards Action Standards Action Procedures ANSI Accreditation Process Evaluation Task Force Application Preliminary Application APPROVED Accreditation Assessment 19

  8. Excipient Certification Program • Benefits • Accredited by nationally recognized organization (ANSI) • Audit duration 4 man-days (plus) • Enhanced assurance of quality system conformance • Quality review of report by IPEA Executive • Certification Board • Review of report • Validation of conclusion visa vie certification • Annual surveillance audit 19

  9. IPEA Excipient Certification Process Application Planning Audit Certified Report Review Certification Review Board 19

  10. Supply Chain Integrity • Excipient Pedigree • Verified Paper Trail • Already in-use • All movements require paperwork (e.g. BOL) • Site audit • Verify distribution • Shipping papers back to original manufacturer • Periodically confirm 19

  11. Supply Chain Integrity • Distributors • Good Distribution Practices • Unopened Package • Plus Good Manufacturing Practices where: • Packaged from bulk • Repackage 19

  12. Supply Chain Integrity • Tamper -evident Seals • Boxes • Embossed Tape • Drums • Embossed Tape • Imprinted Dust Caps • Bulk • Numbered Seals 19

  13. Supply Chain Integrity • Identification of the manufacturer and site • Paperwork (Bill of Lading) traced to Manufacturer • Audit entire supply chain • Certify excipient manufacturer • Certify all distributors • Periodic confirmation of manufacturer • Acknowledgement of Bill of Lading • Confirm Shipment of Lot to Distributor 19

  14. Supply Chain Integrity • Approval of Excipients • Review of COA • Confirm identity of excipient • Identification test • No composite samples! • Periodic confirmation of COA validity • Perform tests • Return COA to manufacturer to confirm authenticity 19

  15. Enhance Excipient Receipt and Approval • Approval of Components • Evaluation of Packaging • Label matches reference label • Tamper-evident seal matches reference seal • Packaging components match reference components 19

  16. Operating without supply chain integrity is like accepting currency without verifying its authenticity. 19

  17. Predicting EMA • Reports of EMA lead to: • Assess potential impact to excipients, e.g. Melamine in pet food and milk • Digestion or combustion nitrogen analysis non-specific for protein • Digestion or combustion nitrogen analysis used for certain USP excipients • Evaluate the potential for certain excipients to be diluted with melamine • Economic advantage? • Pass Quality Control approval? 19

  18. Predicting Vulnerability • Economic Advantage: • Technical vs. Excipient Grade • Latin American customers used PVP versus Povidone USP • Not for Pharmaceutical Use on PVP liners • English and Spanish • Improved test methods • Heterocyclic nitrogen instead of non-specific digestion • Purchase through long supply chain vs. direct from manufacturer 19

  19. Thank you for your attention wwwwww.ipecamericas.org www.ipeainc.com Irwin Silverstein Irwin.s@verizon.net www.ibsquality.com 19