Excipients of Human or Animal Origin

Excipients of human or animal origin should be identified. The genus, species, country of origin, source (e.g., pancreas), and manufacturer or supplier should be clearly indicated. Furthermore, for excipients derived from ruminant materials, the application should state whether the materials are from bovine spongiform encephalopathy countries as defined by the U.S. Department of Agriculture (9 CFR 94.11). 

ICH Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin 

ICH Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 

---

A brief summary on the quality of excipients is to include information on specifications and their justification, analytical procedures and their validation, excipients of human or animal origin, and novel excipients. 

---