IPEC Regulatory Guidance

IPEC-Americas Guidance
Guides are available for purchase (hard copies) or free download from the IPEC Web site.
Go to the IPEC Store

  • IPEC-Americas Distributors Audit Guide For North American Distributors - NEW!
  • IPEC-PQG GMP Guide
  • IPEC-PQG GMP Audit Guide
  • IPEC-Americas Certificate of Analysis Guide
  • IPEC Excipient Information Package
  • IPEC Excipient Information Package - templates in word document
  • IPEC Significant Change Guide
  • IPEC-Americas Excipient MasterFile Guide
  • IPEC Excipient Qualification Guide
  • IPEC Stability Guide
  • IPEC General Glossary of Terms
  • IPEC Composition Guide
  • Quality Agreement Guide
  • Quality Agreement Templates - word document
  • IPEC Good Distribution Practices Guide
  • Excipient Pedigree White Paper