The audits require excipients to be safe, functional, and to comply with GMP requirements. The excipient GMP certification program is accredited by the American National Standards Institute (ANSI), and offers third-party audits based on IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients and excipient GMP certification.
Additionally, NSF International is working with representatives from the chemical and pharma industries and the FDA to develop an NSF/ANSI excipient GMP consensus standard, which 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. Ms. Skutnik-Wilkinson has more than 20 years of experience in technical and regulatory support roles, including leadership positions with Pfizer, Merck and IPEC, where she played a key role in the creation of IPEA.
“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 Ms. Skutnik-Wilkinson.