Adds auditing and certification of excipients to services
NSF International, a global public health organisation that writes standards, and tests and certifies products for the health sciences, water, food and consumer goods industries, has acquired IPEA, the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas).
NSF can now offer auditing and certification of excipients in addition to food additives and dietary supplement ingredients. 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 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 can now offer auditing and certification of excipients in addition to food additives and dietary supplement ingredients
NSF International is also 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. She 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. 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.