Excipient Qualification and Supply Chain Controls

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Excipient Qualification and Supply Chain Controls

  1. 1. FDA Economically Motivated Adulteration Conference 19
  2. 2. Excipient Industry Efforts to Stop EMA <ul><li>Develop trust in your excipient supplier BUT verify </li></ul><ul><ul><li>IPEA Excipient Audit Program </li></ul></ul><ul><ul><li>IPEA Excipient Certification Program </li></ul></ul><ul><ul><ul><li>Conformance to Good Manufacturing Practices (GMP) </li></ul></ul></ul><ul><ul><ul><li>Conformance to Good Distribution Practices (GDP) </li></ul></ul></ul><ul><ul><li>Improve supply chain integrity </li></ul></ul><ul><ul><ul><li>Confirm Excipient Pedigree </li></ul></ul></ul><ul><ul><li>Enhance excipient receipt and approval </li></ul></ul><ul><li>The pharmaceutical company has ultimate responsibility for excipient suitability! </li></ul>19
  3. 3. Supplier Qualification <ul><li>Direct from Manufacturer </li></ul><ul><ul><li>Assess Manufacturer </li></ul></ul><ul><li>Purchased from Distributor </li></ul><ul><ul><li>Must know manufacturer and site </li></ul></ul><ul><ul><li>Must know role of distributor </li></ul></ul><ul><ul><ul><li>Warehousing </li></ul></ul></ul><ul><ul><ul><li>Packaging </li></ul></ul></ul><ul><ul><ul><li>Repackager </li></ul></ul></ul><ul><ul><li>Assess Distributor and Manufacturer </li></ul></ul>19
  4. 4. Supplier Qualification <ul><li>Ideal : Pharmaceutical Manufacturers audit all excipient suppliers </li></ul><ul><li>Impact : Each audit cycle </li></ul><ul><ul><li>Pharmaceutical Manufacturer </li></ul></ul><ul><ul><ul><li>Hundreds to thousands of sites to audit globally </li></ul></ul></ul><ul><ul><ul><ul><li>Pfizer reported 4,000 suppliers after mergers </li></ul></ul></ul></ul><ul><ul><li>Excipient Supplier (ISP) </li></ul></ul><ul><ul><ul><li>Host over 300 site audits at Texas City facility! </li></ul></ul></ul><ul><li>Unsuitable : Questionnaire/paper audit! </li></ul>19
  5. 5. Excipient Audit Program <ul><li>Objective : Substitute IPEA audit for Pharmaceutical manufacturer audit </li></ul><ul><li>Goal : Reduce audit cost through report sharing </li></ul><ul><li>Program : </li></ul><ul><ul><li>1-Day audit by qualified auditors </li></ul></ul><ul><ul><li>Quality review of report by IPEA Executive </li></ul></ul><ul><li>Report available for 2 years </li></ul>19
  6. 6. Excipient Certification Program <ul><li>Accredit to American National Standards Institute </li></ul><ul><ul><li>Develop Auditable Standard </li></ul></ul><ul><ul><li>Document Certification Program </li></ul></ul><ul><ul><li>Create Program Administration </li></ul></ul><ul><ul><li>Establish Objective Expectations </li></ul></ul><ul><ul><li>Create Certification Body </li></ul></ul><ul><ul><li>Prepare Quality Manual </li></ul></ul><ul><ul><li>Host ANSI Assessment </li></ul></ul>19
  7. 7. ANSI Accreditation Process Assessment Application Evaluation Task Force Accreditation APPROVED Preliminary Application 19 Procedures Standards Action Standards Action Standards Action
  8. 8. Excipient Certification Program <ul><li>Benefits </li></ul><ul><ul><li>Accredited by nationally recognized organization (ANSI) </li></ul></ul><ul><ul><li>Audit duration 4 man-days (plus) </li></ul></ul><ul><ul><ul><li>Enhanced assurance of quality system conformance </li></ul></ul></ul><ul><ul><li>Quality review of report by IPEA Executive </li></ul></ul><ul><ul><li>Certification Board </li></ul></ul><ul><ul><ul><li>Review of report </li></ul></ul></ul><ul><ul><ul><li>Validation of conclusion visa vie certification </li></ul></ul></ul><ul><ul><li>Annual surveillance audit </li></ul></ul>19
  9. 9. IPEA Excipient Certification Process Certified Application Planning Audit Report Review Certification Review Board 19
  10. 10. Supply Chain Integrity <ul><li>Excipient Pedigree </li></ul><ul><ul><li>Verified Paper Trail </li></ul></ul><ul><ul><ul><li>Already in-use </li></ul></ul></ul><ul><ul><ul><ul><li>All movements require paperwork (e.g. BOL) </li></ul></ul></ul></ul><ul><ul><li>Site audit </li></ul></ul><ul><ul><li>Verify distribution </li></ul></ul><ul><ul><ul><li>Shipping papers back to original manufacturer </li></ul></ul></ul><ul><ul><ul><li>Periodically confirm </li></ul></ul></ul>19
  11. 11. Supply Chain Integrity <ul><li>Distributors </li></ul><ul><ul><li>Good Distribution Practices </li></ul></ul><ul><ul><ul><li>Unopened Package </li></ul></ul></ul><ul><ul><li>Plus Good Manufacturing Practices where: </li></ul></ul><ul><ul><ul><li>Packaged from bulk </li></ul></ul></ul><ul><ul><ul><li>Repackage </li></ul></ul></ul>19
  12. 12. Supply Chain Integrity <ul><li>Tamper -evident Seals </li></ul><ul><ul><li>Boxes </li></ul></ul><ul><ul><ul><li>Embossed Tape </li></ul></ul></ul><ul><ul><li>Drums </li></ul></ul><ul><ul><ul><li>Embossed Tape </li></ul></ul></ul><ul><ul><ul><li>Imprinted Dust Caps </li></ul></ul></ul><ul><ul><li>Bulk </li></ul></ul><ul><ul><ul><li>Numbered Seals </li></ul></ul></ul>19
  13. 13. Supply Chain Integrity <ul><li>Identification of the manufacturer and site </li></ul><ul><ul><li>Paperwork (Bill of Lading) traced to Manufacturer </li></ul></ul><ul><ul><li>Audit entire supply chain </li></ul></ul><ul><ul><ul><li>Certify excipient manufacturer </li></ul></ul></ul><ul><ul><ul><li>Certify all distributors </li></ul></ul></ul><ul><ul><li>Periodic confirmation of manufacturer </li></ul></ul><ul><ul><ul><li>Acknowledgement of Bill of Lading </li></ul></ul></ul><ul><ul><ul><li>Confirm Shipment of Lot to Distributor </li></ul></ul></ul>19
  14. 14. Supply Chain Integrity <ul><li>Approval of Excipients </li></ul><ul><ul><li>Review of COA </li></ul></ul><ul><ul><li>Confirm identity of excipient </li></ul></ul><ul><ul><ul><li>Identification test </li></ul></ul></ul><ul><ul><ul><ul><li>No composite samples! </li></ul></ul></ul></ul><ul><ul><li>Periodic confirmation of COA validity </li></ul></ul><ul><ul><ul><li>Perform tests </li></ul></ul></ul><ul><ul><ul><li>Return COA to manufacturer to confirm authenticity </li></ul></ul></ul>19
  15. 15. Enhance Excipient Receipt and Approval <ul><li>Approval of Components </li></ul><ul><ul><li>Evaluation of Packaging </li></ul></ul><ul><ul><ul><li>Label matches reference label </li></ul></ul></ul><ul><ul><ul><li>Tamper-evident seal matches reference seal </li></ul></ul></ul><ul><ul><ul><li>Packaging components match reference components </li></ul></ul></ul>19
  16. 16. Operating without supply chain integrity is like accepting currency without verifying its authenticity. 19
  17. 17. Predicting EMA <ul><li>Reports of EMA lead to: </li></ul><ul><ul><li>Assess potential impact to excipients, e.g. Melamine in pet food and milk </li></ul></ul><ul><ul><ul><li>Digestion or combustion nitrogen analysis non-specific for protein </li></ul></ul></ul><ul><ul><ul><li>Digestion or combustion nitrogen analysis used for certain USP excipients </li></ul></ul></ul><ul><ul><ul><ul><li>Evaluate the potential for certain excipients to be diluted with melamine </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Economic advantage? </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Pass Quality Control approval? </li></ul></ul></ul></ul></ul>19
  18. 18. Predicting Vulnerability <ul><li>Economic Advantage: </li></ul><ul><ul><li>Technical vs. Excipient Grade </li></ul></ul><ul><ul><ul><li>Latin American customers used PVP versus Povidone USP </li></ul></ul></ul><ul><ul><ul><ul><li>Not for Pharmaceutical Use on PVP liners </li></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>English and Spanish </li></ul></ul></ul></ul></ul><ul><ul><li>Improved test methods </li></ul></ul><ul><ul><ul><li>Heterocyclic nitrogen instead of non-specific digestion </li></ul></ul></ul><ul><ul><li>Purchase through long supply chain vs. direct from manufacturer </li></ul></ul>19
  19. 19. wwwwww.ipecamericas.org www.ipeainc.com Irwin Silverstein [email_address] www.ibsquality.com 19

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