NSF International, a provider of testing, auditing, certification and training for the pharma industry, has been accredited by the American National Standards Institute (ANSI) to certify excipient manufacturers to the American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
The globalization of the industry, along with a global regulatory focus on preventing counterfeit and adulterated products, led to the need for an updated excipient quality and control standard. The new standard was published by NSF International and the International Pharmaceutical Excipients Council (IPEC) and provides a framework that incorporates the most current regulatory and industry requirements into a single standard for the manufacture and distribution of pharma excipients.
“NSF/IPEC/ANSI 363 incorporates the most current thinking and best practices for pharmaceutical excipient manufacturing and is aligned with major regulatory guidelines such as PQG 2006, ICH Q9 and ICH Q10. Accreditation from the American National Standards Institute is a testament to the high caliber of NSF International’s audit team and their ability to deliver truly independent evaluations against the most comprehensive and current excipient GMP standard available,” said Maxine Fritz, executive vice president of NSF Pharma Biotech Consulting, part of NSF International’s Health Sciences Division.
“Both regulators and industry benefit from the time and cost savings of a harmonized excipient GMP standard like NSF/IPEC/ANSI 363,” said John Giannone, chairman, IPEC-Americas. “IPEC-Americas will be offering training seminars to help the industry better understand the new NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Standard and how it improves upon other global excipient standards.”
The NSF/IPEC/ANSI 363 standard was developed with input from a committee of pharmaceutical excipient experts from regulatory, industry and academic fields. The standard references 14 regulatory guidelines and industry standards for excipients, including U.S. FDA regulations, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC-Americas) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.
