13. July 2018

Historically, excipient manufacturers have relied on the International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group's (PQG's) Joint IPEC-PQG Good Manufacturing Practices (GMP) Guide for Pharmaceutical Excipients [1]. The two organizations issued this guidance in 2006, and it was the product of a significant amount of work by IPEC's members. It provides a great baseline; the industry, however, has moved on.