The QMN Weekly Bulletin

Drugmakers striving to comply with manufacturing regulations 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 VersaPharm, said at a recent conference in Washington, D.C. Ninety percent of inspection citations stem from untrained staff and human error, Raju pointed out.

The FDA has also recognized the value of automation, recently allowing the use of any automated technique for cut labeling to prevent incorrect product labeling and packaging.

Rick Friedman, associate director of CDER’s Office of Manufacturing and Product Quality, has called out drugmakers’ use of antiquated production equipment. He noted the recent run of drug recalls is largely linked to dissolution failures and other variability flubs. But until drug and devicemakers update this equipment, controlling human error is even more critical.

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