excipient qualification and supply chain controls
DESCRIPTION
TRANSCRIPT
FDA Economically Motivated Adulteration Conference
119
Excipient Industry Efforts to Stop EMADevelop 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 approvalThe pharmaceutical company has ultimate
responsibility for excipient suitability!
219
Supplier QualificationDirect from Manufacturer
Assess ManufacturerPurchased from Distributor
Must know manufacturer and siteMust know role of distributor
Warehousing Packaging Repackager
Assess Distributor and Manufacturer
319
Supplier QualificationIdeal: Pharmaceutical Manufacturers audit
all excipient suppliersImpact: 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!
419
Excipient Audit ProgramObjective: Substitute IPEA audit
for Pharmaceutical manufacturer audit
Goal: Reduce audit cost through report sharing
Program:1-Day audit by qualified auditorsQuality review of report by IPEA
ExecutiveReport available for 2 years
519
Excipient Certification ProgramAccredit to American National Standards
InstituteDevelop Auditable StandardDocument Certification ProgramCreate Program AdministrationEstablish Objective ExpectationsCreate Certification BodyPrepare Quality ManualHost ANSI Assessment
619
ANSI Accreditation Process
ProceduresProceduresAssessment
ApplicationStandards
Action
Standards
Action Standards
Action
Evaluation Task Force
Accreditation
APPROVEAPPROVEDD
Preliminary Application
719
Excipient Certification ProgramBenefits
Accredited by nationally recognized organization (ANSI)
Audit duration 4 man-days (plus) Enhanced assurance of quality system
conformanceQuality review of report by IPEA
ExecutiveCertification Board
Review of report Validation of conclusion visa vie
certificationAnnual surveillance audit
819
IPEA Excipient Certification Process
9
Certified
Application Planning Audit
Report Revie
wCertificationReview Board
19
Supply Chain IntegrityExcipient Pedigree
Verified Paper Trail Already in-use
All movements require paperwork (e.g. BOL)
Site auditVerify distribution
Shipping papers back to original manufacturer
Periodically confirm1019
Supply Chain IntegrityDistributors
Good Distribution Practices Unopened Package
Plus Good Manufacturing Practices where: Packaged from bulk Repackage
1119
Supply Chain IntegrityTamper -evident
SealsBoxes
Embossed Tape
Drums Embossed Tape Imprinted Dust Caps
Bulk Numbered Seals
1219
Supply Chain IntegrityIdentification of the manufacturer and
sitePaperwork (Bill of Lading) traced to
ManufacturerAudit entire supply chain
Certify excipient manufacturer Certify all distributors
Periodic confirmation of manufacturer Acknowledgement of Bill of Lading Confirm Shipment of Lot to Distributor
1319
Supply Chain IntegrityApproval of Excipients
Review of COAConfirm identity of excipient
Identification test- No composite samples!
Periodic confirmation of COA validity Perform tests Return COA to manufacturer to confirm
authenticity
1419
Enhance Excipient Receipt and ApprovalApproval of Components
Evaluation of Packaging Label matches reference
label Tamper-evident seal
matches reference seal Packaging components
match reference components
1519
Operating without supply chain integrity is like accepting currency without verifying its
authenticity.
1619
Predicting EMAReports 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?
1719
Predicting VulnerabilityEconomic 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 digestionPurchase through long supply chain
vs. direct from manufacturer
1819
