FDAnews Drug Daily Bulletin

Drugmakers striving to comply with manufacturing regs and stay on the FDA’s good side should turn their attention to preventing human error, an industry official says — and automated systems are key to solving this problem. “You can cut out a lot of human error through computers,” Ram Gadi Raju, regulatory affairs and compliance director at VersaPharma, said at Marcus Evans’ Product and Pipeline Enhancement for Generics conference in Washington, D.C. Ninety percent of inspection citations stem from untrained staff and human error, Raju pointed out.
Drug Industry Daily