From the Editor: Process Knowledge = Patient Safety: Lessons from Mylan Morgantown

How can jidoka, process control and PAT work if a facility’s or company’s culture does not promote the right values?

By Agnes Shanley, Editor in Chief

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This July, the Pittsburgh Post-Gazette reported on events that had allegedly taken place at Mylan Labs, the world’s third largest generics manufacturer, at its manufacturing facility in Morgantown, West Virginia this past Spring.

Two workers had violated quality control procedures, the newspaper reported, by disabling a “red screen,” jidoka-type device, designed to interrupt production and alert QC supervisors of quality problems during tableting. The facility makes generic treatments for epilepsy, diabetes, depression, high blood pressure and cancer. 

According to the newspaper, these allegations triggered a facility-wide probe and plant shutdown. Post-Gazette reporters said they’d obtained confidential internal reports suggesting that operators across all three production shifts had been bypassing control devices for the past two years.

We couldn’t get copies of these reports from the Post-Gazette, but Mylan’s investigation allegedly showed that product quality had not been compromised. The company issued numerous press releases to that effect, also trumpeting new worker training programs.
Around the same time, news of GMP-type compliance problems at Mylan’s Matrix subsidiary plant in India surfaced, fanning the media flames. Among other things, WHO inspectors alleged that operators signed off on batches when they weren’t even physically present in the plant. Mylan Labs’ stock price began to slide.

On August 19, Mylan sued the Post-Gazette and the two reporters who wrote the piece over their coverage of the Morgantown situation, demanding that its allegedly internal documents be returned, and reiterating the fact that product quality was still OK.
But whether product quality was affected or not, in this instance, is completely beside the point. It could have been.

It’s unfair to single out Mylan Labs, because I’m willing to bet that similar things go on every day at every pharmaceutical manufacturing facility in the world. How often are they detected?

To Make a Profit or Save Lives?

For many drug companies today, the question boils down to a simple one, allegedly put to one GMP whistleblower several years ago: “Are we in this business to make a profit or to save lives?” Ideally, you want to do both, but economic pressures, job insecurity and sloppy training and SOPs can make it all too easy to set the wrong priorities.

The fact that Mylan Labs even had an error prevention system in place is commendable. I’m willing to bet that most generics (and even name brand) manufacturers don’t have such devices. But, apparently it was quite easy to override. Had it, and the ancillary computer database, been properly validated?

But these issues are much bigger than one individual company, or the pharmaceutical industry. There is a long and checkered history, spanning all industries, of operators dismantling controls they don’t know well for processes they don’t completely understand.

Consider the nuclear power industry. At the Three Mile Island and Chernobyl power plant accidents, improperly trained operators assumed they were doing the right thing and made several fatal errors. The rest is history.

Nobody was hurt at Mylan’s facility. Product met final lab quality testing criteria. There was no explosion or toxic release. We have not heard of any adverse patient responses.
But how many patients around the world experience adverse affects or die because they receive too much, or too little, active ingredient, and how many of these problems can be traced back to plant-floor issues?

We’ve seen this recently with several generic heart medications. Caraco’s digoxin-based product was recalled after it was found that tablets contained twice the recommended dosage. Patients died from that mistake.

Two years ago, Actavis Totowa’s Digitek heart drug was recalled for similar reasons. Again, patients died.

Ethex Corp’s isosorbide mononitrate angina tablets were recalled for improper API loading.

Perhaps plant operators should take some form of Hippocratic Oath when they start working in the industry: First, do no harm. But maybe that oath should also be required for corporate managers.

Anecdotes abound, in all industries, of what empowered and well-trained workers can do to turn around challenged operations. They understand the need for controls and what can happen when a process is out of control. They also know what may happen if a control system is dismantled.

Empowered operators can only exist when management sets the right priorities and provides the training, tools and perspective. Is this happening where you work?

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