NSF and International Pharmaceuticals Excipients Council encourage manufacturers to achieve certification to demonstrate compliance to multiple regulatory and industry requirements for excipients

ANN ARBOR, Mich. and ARLINGTON, Va. – NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification and training for the pharmaceutical 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 pharmaceutical industry, combined 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). It provides a comprehensive framework that incorporates the most current regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

Excipient manufacturers that earn NSF/IPEC/ANSI 363 certification from an accredited organization such as NSF provide additional assurance of excipient quality to their pharmaceutical customers. Additionally, an accredited NSF/IPEC/ANSI 363 Certificate of Conformance from NSF may replace the need for multiple audits from suppliers, saving manufacturers cost associated with audit redundancy and production disruption.

“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’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 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-Americas) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.

For more information about NSF’s Excipient Certification Program, please contact Austin Caudle at +1 734-545-3376 or 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 contact NSF International Communications Manager Liz Nowland-Margolis at media@nsf.org

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. NSF Health Sciences Certification, LLC does not provide consulting services and use of any NSF International consulting service does not, in any way, make certification simpler, easier, faster or less expensive. NSF Health Sciences Certification, LLC makes its certification evaluations and decisions impartially and independent from any NSF International activity.

About IPEC – Americas: IPEC- Americas is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with our counterparts in Europe, China and Japan serves as primary international resource on excipients for its members, governments and public audiences.