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.
01. April 2015
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...
12. March 2015
Consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients ANN ARBOR, Mich. – Global public health organization NSF International has published the first American National Standard for pharmaceutical excipients - NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. The new standard and auditing program assists pharmaceutical companies in...