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IPEC Federation & Europe Guidelines

  1. IPEC Quality-by-Design Guide – Version 2 – 2025
  2. IPEC Good Distribution Practices Guide (GDP) – Version 3 – 2024
  3. IPEC Certificate of Analysis (CoA) Guide – Version 2.1 – 2024
  4. IPEC Quality Agreement – Guide – Version 3 – 2024
  5. IPEC Quality Agreement – Templates – Version 3 – 2024
  6. IPEC Technically Unavoidable Particle Profile (TUPP) Guide – Version 2 – 2024
  7. IPEC General Glossary of Terms and Acronyms – Version 3 – 2023
  8. IPEC Significant Change Guide – Version 5 – 2023
  9. IPEC Excipient Information Package User Guide – Sustainability – Version 1 – 2023-Part 4- Sustainability Overview
  10. IPEC Excipient Stability Guide – Version 2 – 2022
  11. IPEC-PQG Good Manufacturing Practices Guide – Version 5 – 2022
  12. IPEC Safety Guide – Version 1 – 2021
  13. IPEC Good Distribution Practices (GDP) Audit Guide – Version 3 – 2021
  14. IPEC Validation Guide – Version 1 – 2021
  15. IPEC Excipient Information Package User Guide – Version 4 – 2020
  16. IPEC Excipient Information Package Templates – Version 4 – 2020
  17. IPEC Qualification of Excipients Guide – Version 2 – 2020
  18. IPEC GMP Certification Scheme and CB Qualification Guide – Version 1 – 2020
  19. IPEC Excipient Composition Guide – Version 2 – 2020
  20. PDA-IPEC Technical Report 54.6 Formalized Risk Assessment for Excipients – Version 1 – 2019