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Organization’s PAI portfolio boosts drug R&D, process development for pharma manufacturers
The United States Pharmacopeia (USP), an independent, scientific nonprofit organization, has launched a new portfolio of impurities materials to support pharma manufacturers’ efforts to accelerate and strengthen analytical R&D and process development. USP Pharmaceutical Analytical Impurities (PAIs) support impurity analysis and profiling requirements during drug development and throughout the product lifecycle.
Changes in the pharma industry, including new manufacturing processes, more complicated drug formulations, and an increasingly complex global supply chain, are making it more difficult for companies to assess and control for impurities, USP points out. Beginning in 2018, a wave of drug recalls due to nitrosamine impurities has heightened awareness and attention on the potential consequences of impurities in medicines. Growing scrutiny of impurities by different regulators throughout the world is creating uncertainty for companies trying to bring new products to market.
"Pharmaceutical manufacturers have told us time and again, that getting the impurities they need when they need them, can be difficult. But that it's critical for advancing their analytical R&D and process development," says John Giannone, USP’s VP of industry programs.
US law expressly recognizes USP quality standards for medicines. Drug products marketed in the US are expected to meet quality specifications in more than 4,000 monograph standards in USP-NF.