NSF International, a public health organization, has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas): IPEA. As a result of the acquisition, NSF-IPEA now can provide 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, NSF-IPEA offers third-party audits based on IPEC – PQG GMP Guide for pharmaceutical excipients and excipient GMP certification, the organization reports.
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. Skutnik-Wilkinson has 20 years of experience in technical and regulatory support roles for the pharmaceutical industry including leadership positions with Pfizer, Merck, and IPEC.
The IPEA program auditors will remain and additional auditors will be trained and certified by the International Register of Certificated Auditors. The certification board and the procedures will remain as they were under IPEC-Americas.
Source: NSF International