The first American National Standard for pharmaceutical excipients was published last week by international public health organization NSF International.
According to NSF International, most pharmaceutical formulations contain 70-90 percent excipients, serving as taste-maskers, glidants, anti-oxidants, flow aids, binding agents or other functions that facilitate the manufacturing process and improve the chemical stability of pharmaceuticals.
The new consensus-based standard and auditing program is designed to make it easier for pharmaceutical companies to verify regulatory compliance and to strengthen safety and quality throughout the excipient supply chain. It incorporates a broad range of regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.
Developed in partnership with the International Pharmaceutical Excipients Council (IPEC), the NSF/IPEC/ANSI 363 standard references 14 regulatory guidelines and industry standards for excipients, including U.S. 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.
"Through developing NSF/IPEC/ANSI 363 and its corollary certification program, NSF International is providing a means for excipient suppliers to demonstrate to pharmaceutical manufacturers that they meet the necessary GMP (Good Manufacturing Practices) requirements, while also assisting regulators and regulated companies with ensuring the quality of the global pharmaceutical supply chain," said Maxine Fritz, executive vice president of Pharma Biotech at NSF Health Sciences, a division of NSF International.
"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 harmonized excipient GMP standard like NSF/IPEC/ANSI 363," added John Giannone, chairman of IPEC-Americas.
