Bad batches more likely from offshore.

• Position: Drug quality control from offshore manufacturing plants - Pharmaceuticals

Drugs produced in offshore manufacturing plants--even those run by American manufacturers--pose a greater quality risk than those prepared in tile mainland U.S.. suggests a study at Ohio State University. Columbus. 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 U.S. mainland.

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The results show how difficult it is to transfer world-class quality control to an offshore plant, even under the best of conditions, notes John Gray, lead author of time study and assistant professor of operations at the 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 indicates. "We believe time quality differences we found in Puerto Rican plants were driven by challenges in transferring knowledge from headquarters to the plant, due to cultural differences in language and values.

The Puerto Rican plants were compared to those on the U.S. mainland owned by the same companies. and manufacturing the same or similar drugs. The re searchers found that quality was not related to the distance between the plant and the company headquarters, time education of the local population near the plant...