IPEC-Americas Position Paper
Implementation of the NSF/IPEC/ANSI 363 – 2014 Excipient GMP Standard
The American National Standards Institute (ANSI) excipient Good Manufacturing Practices standard NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients (NSF/IPEC
363) was approved December 2014 and, since then, has been available for implementation. This paper describes the position of IPEC-Americas on implementation by excipient manufacturers, and use in
GMP assessments by excipient users.