nsf international announces updated gmp standard … · “this update was completed by the nsf...
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NSF INTERNATIONAL ANNOUNCES UPDATED GMP STANDARD FOR PHARMACEUTICAL EXCIPIENTSAnn Arbor, Mich., April 7, 2020
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 ISO9001:2015 (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, 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.
NSF’s health sciences services include training and education, consulting, clinical research, regulatory guidance, corporate compliance and, separately, auditing, GMP and GLP analytical testing, DNA testing, certification and R&D for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF facilitated the development of the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
ANNOUNCMENT
NSF INTERNATIONAL789 N. Dixboro Road, Ann Arbor, MI 48105 USA | www.nsf.org
For additional information, please contact [email protected].
Jim Morris has over 25 years of pharmaceutical management experience in both plant operations and corporate offices, working with Pfizer, Cilag AG and Mass Biologics in the U.S. and Europe.
He has held positions as Deputy Director QA/QC and Regulatory Affairs while at Mass Biologics, Director of QA/QC for the Biologics business unit of Cilag AG and a number of quality assurance and manufacturing roles with Pfizer over a 16-year timeframe, culminating as the head of Quality Assurance for Pfizer in Latina, Italy.