An international public health group on Wednesday announced new standards for the production of inactive ingredients in pharmaceuticals.
Michigan-based NSF International, which sets public health standards and certification programs for a wide range of industries, said standardized manufacturing practices for excipients would help drug companies verify regulatory compliance and ensure safety throughout its supply chain.
The group said most pharmaceuticals contain between 70 and 90 percent excipients, which can improve the products’ chemical stability or manufacturing processes, as well as serve as “taste-maskers, glidants, anti-oxidants, flow aids (or) binding agents.” The increased globalization of the pharmaceutical industry and concerns over counterfeit and contaminated drugs led NSF to begin development of its first excipient standards.
NSF International developed the policies in partnership with the International Pharmaceutical Excipients Council; the publication references guidelines from agencies including the Pharmaceutical Quality Group and the U.S. Food and Drug Administration.
“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, an executive with NSF Health Sciences.