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 verifying regulatory compliance and strengthening safety and quality throughout the excipient supply chain.

Most pharmaceutical formulations contain 70-90 percent excipients, which serve as taste-maskers, glidants, anti-oxidants, flow aids, binding agents or other purposes that facilitate the manufacturing process and improve chemical stability of pharmaceuticals. The globalization of the pharmaceutical industry combined with a global regulatory focus on preventing counterfeits and adulterated products has created a need for a comprehensive excipient quality and control standard. For example, the Food and Drug Administration Safety and Innovation Act (FDASIA) now requires U.S. manufacturers to verify and document that the raw materials used in finished products are also meeting appropriate GMPs. The NSF/IPEC/ANSI 363 standard for pharmaceutical excipient GMPs provides a harmonized and comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients worldwide.

The NSF/IPEC/ANSI 363 standard was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) with balanced 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. Food and Drug Administration regulations, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.

“Through developing NSF/IPEC/ANSI 363 and its corollary certification program, NSF International is providing a means for excipient suppliers to demonstrate to pharmaceutical manufacturers that they meet the necessary GMP requirements, while also assisting regulators and regulated companies with ensuring the quality of the global pharmaceutical supply chain,” said Maxine Fritz, Executive Vice President Pharma Biotech, NSF Health Sciences, a division of NSF International.

“Excipient manufacturers certified to the NSF/IPEC/ANSI 363 standard demonstrate that their excipients are manufactured to the appropriate GMPs for pharmaceutical use, which in most cases results in fewer customer audits. 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.

Pharmaceutical companies purchasing excipients certified to the NSF/IPEC/ANSI 363 standard are provided additional assurance of excipient quality and can elect to purchase audit reports. For more information about NSF International’s pharmaceutical excipient auditing program, please contact Austin Caudle by phone +1 734-545-3376 or email excipients@nsf.org, or visit NSF International’s website. To purchase a copy of NSF/IPEC/ANSI 363, visit the NSF International bookstore.

Editor’s note: If you would like to set up an interview with an excipient quality expert, please email Communications Specialist Kelly Ingerly at media@nsf.org or call 734-827-6850.

About NSF International: NSF International is a global independent organization that writes standards, and tests and certifies products for the health sciences, food, water and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment. The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP analytical testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device and dietary supplement industries throughout the product lifecycle.