But The Wall Street Journal (Oct.25, 2012) reports that the sample size that was tested was too small to be meaningful and didn’t comply with industry guidelines. The Oklahoma City testing lab had examined just two 5-milliliter vials of the NECC drug, and found them to be both sterile. The vials came from a batch of 6,528 implicated by the CDC.
Drug makers and compounding pharmacies routinely have their drugs tested by labs as a quality-control measure. Industry experts say such testing can never completely rule out contamination unless every vial in a batch is tested, which is economically impractical. In the case of the NECC steroids tainted with fungi, the size of the testing sample—two vials—is much smaller than the industry standard for the test; for a batch of more than 6,000 vials, the lab should have tested at least 20. And one drug-testing laboratory quoted in The Journal typically asks for double the number of samples called for in the US standards. “If they’re only testing two vials out of a batch of 6,000, the chances of finding a contaminated vial are very small. Half the batch could be contaminated, and you’d never find it,” says the firm.
For a test to detect contamination with 95% confidence, 18% of the batch would have to be tested, adds a Bristol-Myers executive. “You cannot test quality into a product. You’ve got to manufacture a product in a controlled way and only then does the testing mean anything”.
Discussion questions
1. Ask your students to read Supplement 6’s discussion of Acceptance Sampling and comment on NECC’s approach to quality.
2. Why can’t every vial be tested?