ANN ARBOR, Mich. USA — NSF International, a global public health organization, has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas): IPEA. These audits are important as U.S. and European regulations, and pending regulations in Brazil and China, require excipients to be safe, functional and to comply with Good Manufacturing Practices (GMP) requirements. As a result of the acquisition, NSF-IPEA now can provide expedited excipient auditing and certification as part of NSF’s Health Sciences Pharma Biotech Division and clients can also obtain bundled excipient, food additive and dietary supplement ingredient audits from NSF.
As the only excipient GMP certification program accredited by the American National Standards Institute (ANSI), NSF-IPEA offers third-party audits based on IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients and excipient GMP certification.
A global leader in product certification and standards development for 70 years, NSF International developed American National Standard (NSF/ANSI 173) which establishes safety and quality requirements for dietary supplements. Additionally NSF provides GMP and Good Laboratory Practices (GLP) testing, certification, R&D and regulatory guidance for the pharma, medical device and dietary supplement industries.
NSF International is working with representatives from the chemical and pharma industries and FDA staff to develop an NSF/ANSI excipient GMP consensus standard. The standard, expected to be completed this year, defines GMPs for excipient manufacture for use in drug products and specifies the components of a quality management system for excipient manufacture.
NSF Health Sciences Pharma Biotech Vice President Janeen Skutnik-Wilkinson will lead the excipients program in the same manner as it was managed by IPEC. Skutnik-Wilkinson has more than 20 years of experience in technical and regulatory support roles for the pharmaceutical industry including leadership positions with Pfizer, Merck and IPEC, where she played a key role in the creation of IPEA.
The IPEA program auditors will remain and additional auditors will be trained and certified by the International Register of Certificated Auditors (IRCA). The certification board and the procedures will remain as they were under IPEC-Americas. “NSF International shares IPEA’s long-standing commitment to excipient safety. Our expertise in standards development and certification will help excipient manufacturers globally build credibility and save time and money by benefiting from bundled audits and streamlined certification services,” said Skutnik-Wilkinson.
Through her extensive work with IPEC, government and industry groups, Skutnik-Wilkinson has helped shape key regulations and quality standards that have improved pharmaceutical quality and global supply chain practices. She helped establish IPEA’s Excipient GMP Conformance Certification Program, the only ANSI-accredited provider of excipient GMP certification.
For more information on NSF International’s Health Sciences auditing services, contact Austin Caudle at 734-545-3376 or excipients@nsf.org or visit the NSF Health Sciences Pharma Biotech Division website.
Editor’s note: Media can contact Greta Houlahan at media@nsf.org or 734.913.5723 to set up an interview.
About NSF International: NSF International is an independent global organization that writes standards, and tests and certifies products for the food, water, consumer goods and health sciences 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. Operating in more than 150 countries, 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 testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product life cycle. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.
NSF International offers ISO 13485 registrations for medical devices and CE marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Global Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through NSF Training and Education.
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