Standard for Excipient GMPs Reflects Industry Consensus

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A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.


NSF International has published a standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. The standard and auditing program were developed to assist pharmaceutical companies in verifying regulatory compliance and strengthen safety and quality throughout the excipient supply chain.

The NSF/IPEC/ANSI 363 standard was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) with 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.

The globalization 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, NSF reports in a press statement.

The Food and Drug Administration Safety and Innovation Act (FDASIA) 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 harmonized and comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients worldwide, according to NSF.


“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,” 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 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,” said John Giannone, chairman, IPEC-Americas.

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, according to an NSF statement.

Source: NSF International