To help India’s pharmaceutical excipient manufacturers demonstrate regulatory compliance, safety and quality
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. The new standard and auditing programme assists Indian manufacturers in demonstrating the regulatory compliance, safety and quality of their excipient products to pharma manufacturers in the US and worldwide.
Most pharma formulations contain 70-90 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 pharma. The globalisation of the pharma 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 pharma excipient GMPs provides a harmonised and comprehensive set of criteria for the quality management systems used in the manufacture of pharma 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 pharma 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 programme, NSF International is providing a means for excipient suppliers to demonstrate to pharma manufacturers that they meet the necessary GMP requirements, while also assisting regulators and regulated companies with ensuring the quality of the global pharma supply chain,” said 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 pharma 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,” said John Giannone, Chairman, IPEC-Americas.
EP News Bureau – Mumbai