Experts say robust quality systems, if taken to heart, can play a key role in preventing and recovering from manufacturing failures like the ones that have struck Genzyme Corp. and Johnson & Johnson in recent months. FDA, the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency have all recommended that drug makers adopt quality systems outlined in the International Conference on Harmonization's latest guidelines. Without such systems, says Deborah Autor, director of compliance at FDA's center for drugs, "A company can be riding along and everything seems fine and there's a tragedy of some sort and the brand just sinks. And that's obviously not a situation that any of us want to find."
Take what's happened at Genzyme. Last year, after repeated manufacturing violations, a virus contaminated a bioreactor at Genzyme's Allston, MA, plant, forcing the company to shut it down over the...
