NSF International has acquired the International Pharmaceutical Excipients Council of the Americas’ (IPEC-Americas) auditing subsidiary, IPEA.
These audits are important as US 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 programme 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 programme 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 programme 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," Skutnik-Wilkinson. "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."
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.