April 2020

NSF International Announces Updated GMP Standard for Pharmaceutical Excipients

The NSF/IPEC/ANSI 363-2019: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients standard has been revised to align more closely with the structure of ISO 9001:2015 (EN) Quality Management Systems – Requirements.

NSF/IPEC/ANSI 363 defines minimum GMP standards for the manufacture and distribution of pharmaceutical excipients. Certification to this standard serves as a communication tool between manufacturers of excipients and finished product manufacturers, pharmaceutical regulators, pharmacy organizations and consumers.

“NSF/IPEC/ANSI 363 was developed with participation from pharmaceutical excipient manufacturers, public health regulators and users of pharmaceutical excipients,” said James Morris, Executive Director of Health Sciences at NSF International. “This update was completed by the NSF Joint Committee on Pharmaceutical Excipients to align the NSF/IPEC/ANSI 363 GMP standard more closely with ISO 9001 and the EXCiPACT 2017 GMP Standard for Pharmaceutical Excipients.”

Manufacturers can purchase the standard from the ANSI webstore. Please direct media inquiries to Ken Bearden at media@nsf.org or +1.734.769.5167.