ANN ARBOR, Mich.NSF International, a global public health organization, has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), International Pharmaceutical Excipients Auditing, Inc (IPEA). As a result of the acquisition, NSF-IPEA can provide expedited excipient auditing and certification as part of NSFs Health Sciences Pharma Biotech division and clients can also obtain bundled excipient, food additive and dietary supplement ingredient audits from NSF. These audits are important because U.S. and European regulations, and pending regulations in Brazil and China, require excipients to be safe, function and to comply with good manufacturing practices (GMP) requirements.
NSF-IPEA is the only excipient GMP certification program accredited by the American National Standards Insititute (ANSI) and offers third-party audits based on IPEC PQG (Pharmaceutical Quality Group) Good Manufacturing Practices Guide for Pharmaceutical Excipients and excipient GMP certification.
NSF is working to develop an NSF/ANSI excipient GMP consensus standard with representatives from the chemical and pharma industries, as well as FDA staff. This standard is expected to be completed this year and defines GMPs for excipient manufacturers to use in drug products and specifies the components of a quality management system for excipient manufacturing.
NSF International shares IPEAs 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 NSF Health Sciences Pharma Biotech vice president Janeen Skutnik-Wilkinson.
NSF International in an independent global organization that writes standards and tests and certifies products for the food, water, consumer goods and health sciences industries. The health sciences division offers training and education, consulting, auditing, GMP testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product life cycle.