The NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification, and training for the pharmaceutical industry, has been accredited by the American National Standards Institute (ANSI) to certify excipient manufacturers to the American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. The new standard was published by NSF International and the International Pharmaceutical Excipients Council (IPEC).
Excipient manufacturers that earn NSF/IPEC/ANSI 363 certification from an accredited organization such as NSF provide additional assurance of excipient quality to their pharmaceutical customers. Additionally, an accredited NSF/IPEC/ANSI 363 Certificate of Conformance from NSF may replace the need for multiple audits from suppliers, reducing cost associated with audit redundancy and production disruption.
The NSF/IPEC/ANSI 363 standard was developed with input from a committee of pharmaceutical excipient experts from regulatory, industry, and academic fields. The standard references 14 regulatory guidelines and industry standards for excipients, including US Food and Drug Administration regulations, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC-Americas) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.