Drugs produced in offshore plants pose an increased quality risk compared to those prepared in the mainland United States, a new study suggests. The study was published in the Journal of Operations Management and specifically compared regulated drug manufacturing plants in the U.S. mainland and Puerto Rico.
OK, we kinda, sorta knew that (cf. examples from GlaxoSmithKline, Johnson & Johnson, Bristol-Myers Squibb, and Baxter) but it's nevertheless eye-opening to have this proven out.
What's scary is that language - and, presumably, translation - play an important role in those quality issues. The study's lead author noted:
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.Scarier still is the author's contention that
Facilities in more distant, less developed countries may face even greater obstacles to quality control than what we found in Puerto RicoThat is disheartening news for consumers and medical translators alike. Is the clock running on another Heparin scandal, just this time with a language twist?
[Thank you, Pharmalot, for the heads-up!]
For more on this topic, take a look at the following:
- Drug safety down, translation demand up
- Managing quality in global supply chain
- The clock is running on another Heparin
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