Regulatory References

General Regulatory Links


United States

* Links to FDA email addresses regarding specific regulatory questions

* FDA Common Excipient Guidance Documents and Related Pages

* FDA Common Excipient Related Web Pages

Europe


Product Regulatory Data Sheet
Regulatory Information Compendia/Regulations

Compendia/Regulations

Regulatory Information - BSE/TSE

Allergens

Regulatory information – GMOs

Miscellaneous


Site Quality Overview

IPEC Excipient GMP Related Guidance Documents (Guides are available in the Document Depot, inside the Reference Center)

Compliance evidence:

IPEC GMP compliance details

  • IPEC-PQG GMP Audit Guide for Pharmaceutical Excipients (this guide is available in the Document Depot, inside the Reference Center)

Miscellaneous site information


Site and Supply Chain Security Overview 

Site and supply chain security

Security information

Safety and environmental information