COLUMBUS, Ohio—Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland United States, according to a new study.
Researchers found that drugs produced in Puerto Rican plants owned and operated by U.S. pharmaceutical firms were more likely to have quality problems than those produced by the same firm in a matched plant on the United States mainland.
The results show how difficult it is to transfer world-class quality control to an offshore plant, even under the best of conditions, said John Gray, lead author of the study and assistant professor of operations at Ohio State University’s Fisher College of Business.
“Many people, including some pharmaceutical executives, think offshore plants can produce drugs at significantly less cost but with the same quality risk as plants in the U.S. But we found that may not always be the case,” Gray said.
“We believe the quality differences we found in Puerto Rican plants were driven by challenges in transferring knowledge from headquarters to the plant, due to cultural differences, primarily differences in language and values.”
The study findings accounted for many of the alternative explanations about why offshore plants may have lower quality than those on the U.S. mainland.