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IPEC Federation & Europe Guidelines

  1. General Glossary of Terms and Acronyms – Updated
  2. Validation Guide
  3. Qualification of Excipients Guide
  4. Excipient Information Package Templates
  5. Excipient Information Package User Guide & Template
  6. GMP Certification Scheme and Certification Body Qualification Guide For Pharmaceutical Excipients
  7. PQG Good Manufacturing Practices Guide
  8. Excipient Composition Guide
  9. Good Distribution Practices Guide
  10. Technically Unavoidable Particle Profile (TUPP) Guide
  11. PDA-IPEC Technical Report 54.6 – Table of Contents
  12. Quality Agreement Guide and Template(s)
  13. Significant Change Guide for Pharmaceutical Excipients
  14. QA – Manufacturer’s Quality Statement
  15. QA Responsibility Table – Manufacturer’s Template
  16. QA Responsibility Table – Distributor’s Template
  17. How-To’ Document on EU Guidelines on Risk Assessment for Excipients
  18. Certificate of Analysis Guide for Pharmaceutical Excipients
  19. Co-processed Excipient Guide
  20. Good Distribution Practices Audit Guideline
  21. Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design (QbD)
  22. Le Guide des Bonnes Pratiques de Fabrication des Excipients Pharmaceutiques
  23. Risk Assessment Guide for Pharmaceutical Excipients Part 1 – Risk Assessment for Excipient Manufacturers
  24. Stability Program Guide
  25. The Joint Good Manufacturing Practices Guide