National Science Foundation (NSF) has published 1st American Standard on GMP for pharmaceutical excipients

The National Science Foundation (NSF), a United States government agency has published first American standard on GMP for pharmaceutical excipients (NSF/IPEC/ANSI 363). The NSF/IPEC/ANSI 363 standard for pharmaceutical excipient GMPs provides a harmonised and comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients worldwide. The NSF/IPEC/ANSI 363 standard was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) with balanced input from a committee of pharmaceutical excipient experts from regulatory, industry and academic fields. The standard references 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) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients. As most of pharmaceutical formulations contain 70 to 90 per cent excipients these new standard and auditing programme will assist Indian and other country manufacturers in demonstrating the regulatory compliance, safety and quality of their excipient products to pharmaceutical manufacturers in the US and worldwide.

John Giannone, chairman, IPEC-Americas during a conversation stated “Excipient manufacturers certified to the NSF/IPEC/ANSI 363 standard demonstrate that their excipients are manufactured to the appropriate GMPs for pharmaceutical use, which in most cases results in fewer customer audits. Both regulators and industry benefit from the time and cost savings of a harmonised excipient GMP standard like NSF/IPEC/ANSI 363.