Global public health organisation NSF International has published the first American National Standard for pharmaceutical excipients - NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.

India’s pharmaceutical excipient manufacturers can now demonstrate compliance with new US Good Manufacturing Practices Consensus-based standard which incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing of pharmaceutical excipients.

The new standard and auditing programme will assist Indian manufacturers in demonstrating the regulatory compliance, safety and quality of their excipient products to pharmaceutical manufacturers in the US and worldwide.

Most pharmaceutical formulations contain 70 to 90 per cent excipients, which serve as taste-maskers, glidants, anti-oxidants, flow aids, binding agents or other purposes that facilitate the manufacturing process and improve chemical stability of pharmaceuticals.

The globalisation of the pharmaceutical industry combined with a global regulatory focus on preventing counterfeits and adulterated products has created a need for a comprehensive excipient quality and control standard. For example, the Food and Drug Administration Safety and Innovation Act (FDASIA) now requires US manufacturers to verify and document that the raw materials used in finished products are also meeting appropriate GMPs.

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 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) 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 requirements, while also assisting regulators and regulated companies with ensuring the quality of the global pharmaceutical supply chain,” says Maxine Fritz, executive vice president, Pharma Biotech, 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 harmonised excipient GMP standard like NSF/IPEC/ANSI 363,” says John Giannone, chairman, IPEC-Americas.

NSF International is a global independent organisation that writes standards, and tests and certifies products for the health sciences, food, water and consumer goods industries.