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IPEC Federation & Europe Guidelines

  1. Certificate of Analysis Guide For Pharmaceutical Excipients
  2. Quality Agreement Guide and Template(s)
  3. 2024-IPEC-QA-Template-F (Word File)
  4. Technically Unavoidable Particle Profile (TUPP) Guide
  5. General Glossary of Terms and Acronyms
  6. Significant Change Guide
  7. Excipient Information Package User Guide and Template
  8. IPEC Excipient Information Package Templates (word File)
  9. Excipient Stability Guide
  10. The Joint Good Manufacturing Practices Guide  For Pharmaceutical Excipients
  11. Safety Guide
  12. Good Distribution Practices Audit Guide
  13. Validation Guide
  14. Excipient Information Package User Guide and Template
  15. Qualification of Excipients for Use in Pharmaceuticals  Guide & Checklist
  16. GMP Certification Scheme and Certification Body Qualification Guide
  17. Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD)
  18. Composition Guide
  19. Technical Report No. 54-6  Formalized Risk Assessment for Excipients
  20. Good Manufacturing Practices Guide