Automation & Control / QRM Process

From the Editor: Operator Error: Does the Industry Have ADD?

Human error is something that drug manufacturers can no longer ignore, as a recent drug recall shows.

By Agnes Shanley, Editor in Chief
ashanley@putman.net


A new television commercial for the drug Strattera shows a distraught adult haunted by the many demands in her life, as film clips of a demanding boss, coworkers and fighting children at home all flash by. A voiceover asks, “Do you have adult attention deficit disorder?”

Cell phones, PDAs and laptops have ushered in the age of multitasking. At the same time, we’ve learned to categorize, and perhaps mischaracterize, every nuance of human behavior, and trace it to a simple -- preferably curable -- source.

As our study of the brain moves forward, we hear that Michaelangelo and Newton really had Asperger’s syndrome and that Bill Gates is “in the autistic spectrum.” The child next door is hyperactive and taking Ritalin, while his mother, in the commercial, is on Strattera. The cartoonist Roz Chast parodied this situation memorably, in a cartoon that showed what various geniuses would have been like if they’d taken the antidepressant, Prozac. Instead of his immortal poem “The Raven,” Edgar Allan Poe was shown writing “Hello, birdie.”

The pharmaceutical industry has not hurt from this trend, and only time will tell whether Attention Deficit Disorder and hyperactivity, or the combined ADHD really are bona fide diseases. But I couldn’t help but think of this recently, when word came out that a Georgia-based pharmaceutical company had to recall an entire lot of an ADHD medication that contained up to three times the active ingredient required.

Fewer than 500 bottles from this lot are in circulation, but one can only hope that this medicine doesn’t reach any children. The fact that errors like this can occur in an industry as heavily regulated as pharmaceuticals is still shocking, especially given the time, resources and sheer paper devoted to quality assurance and control.

More than anything, this case shows the need for process analytical technologies in the manufacturing world today. Pharmaceutical plant operators, like everyone else in this world, are struggling in a downsized world where they, too, must multitask.

In addition, in some cases, they must overcome a cGMP mindset at their companies that prevents common-sense solutions for error-proofing. Last year, I heard one expert relate how quality bureaucrats at one biotech firm resisted when operators suggested that two very different reagents used in one manufacturing process be stored in different-colored bottles. Instead, they were stored in identical bottles in the same cabinet, as batches were wasted and worker safety compromised.

More companies are fighting this bureaucratic system with operational excellence programs incorporating poka yoke, or error proofing and such techniques as 5-S (short for sort, set in order, shine, schedule and score), a method for organizing the manufacturing workplace.

But why shouldn’t instrumentation and controls be in place to help operators in their work and guarantee that active ingredients are present in the right amount? January’s IFPAC Conference in Washington D.C. showed what the future might bring to every drug company, large and small: 3-D imaging systems based on process tomography, NIR and Terahertz spectroscopy, providing a three-dimensional picture of all the ingredients in a tablet as it is being made. Pfizer and Glaxo are in the forefront of those pioneering this work.

Operator error in the drug industry doesn’t manifest itself as it does in the nuclear or chemical industries: typically, there’s no big bang, no huge plant explosion--- only millions of dollars in consent decree fines, or, worse, the silent explosions that occur when a life is diminished or snuffed out. Clearly, more companies need to pay closer attention to human error within their manufacturing plants. Unlike some of the maladies -- real or imagined -- in the news today, this one really does have some cures. PAT is first among them.

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