NSF International has published the first American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
The standard and auditing program assists pharmaceutical companies in verifying regulatory compliance and improving safety and quality throughout the excipient supply chain.
Most pharmaceutical formulations contain 70%-90% excipients, which serve as taste-maskers, glidants, anti-oxidants, flow aids and binding agents 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.
The NSF/IPEC/ANSI 363 standard for pharmaceutical excipient GMPs provides a 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 Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), IPEC and Pharmaceutical Quality Group (PQG).
NSF Health Sciences Pharma Biotech executive vice-president Maxine Fritz said: "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."
IPEC-Americas chairman John Giannone said: "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."
Pharmaceutical companies purchasing excipients certified to the NSF/IPEC/ANSI 363 standard are provided additional assurance of excipient quality and can elect to purchase audit reports.