NSF International publishes first Standard for pharmaceutical excipients

The NSF/IPEC/ANSI 363 Standard and the auditing program help pharmaceutical companies to enhance safety and quality throughout the entire excipient supply chain

Pharmaceutical formulations can contain as much as 90% excipients. These anti-oxidants, flow aids, taste-maskers, glidants, binding agents and other ingredients facilitate the manufacturing process and improve the chemical stability of pharmaceuticals. NSF/IPEC/ANSI 363-2014: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients offers a comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients.

Prevention of counterfeits and adulterated products

The need for a comprehensive excipient standard is not only a result of the globalization of the pharmaceutical industry but also of the current focus on preventing counterfeits and adulterated products.

The FDASIA (Food and Drug Administration Safety and Innovation Act) demands that U.S. manufacturers check and document that also the raw materials they use in their products meet GMPs.

14 regulatory guidelines and industry standards for excipients referenced

The NSF/IPEC/ANSI 363 standard references 14 regulatory guidelines and industry standards, such as U.S. FDA (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) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients. For its development NSF International partnered with the IPEC (International Pharmaceutical Excipients Council) while a committee of pharmaceutical excipient experts from regulatory, industry and academic fields provided balanced input.

NSF/IPEC/ANSI 363 for additional assurance

Excipients certified to the NSF/IPEC/ANSI 363 standard offer additional quality assurance and pharmaceutical companies can elect to purchase audit reports. To read more about the excipient cGMP Audits, visit the NSF website.