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Efforts to Ensure Excipient Safety

Efforts to Ensure Excipient Safety. FDA Economically Motivated Adulteration Conference. Excipient Industry Efforts to Stop EMA. Develop trust in your excipient supplier BUT verify IPEA Excipient Audit Program IPEA Excipient Certification Program

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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

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