Mylan Labs and Pharma's Little Chernobyls

Aug. 11, 2009

Recent news of operators overriding built-in jidoka and control systems at Mylan Labs is a repetition of what has happened in other industries, ever since more advanced IT and automation made better process control possible.  Not trusting the newer systems, people almost always revert to more familiar manual systems.  Only training of the right kind can promote trust and better reliance on automation.

Fortunately, there was no impact on Mylan’s product quality, as the company made clear in its many followup statements, some of them involving FDA.

It’s not what happened, but what might have happened, that’s the issue.  That’s why process control and PAT are so important.

And it is unfair to single out Mylan, because I’m sure that this kind of thing happens all the time in all sorts of industries, pharma among them.  In fact, I wonder how many smaller companies, or generic drug manufacturers, even have the "red screen" controls that Mylan had put in place?  (Too bad they were so easily overriden...suggesting need for better validation, among other things)

This same thing happened in 1986, in the Ukraine.  Bela Liptak’s recent commentary on Chernobyl and how it could have been avoided offers strong lesson for pharma----note the emphasis on process understanding, and what happens without it.

Individual patient’s adverse reactions may not have the same impact as a nuclear catastrophe, but they do add up. More on pharma's ADD regarding operator training here.

Operator training, and empowerment, in the context of KPI’s, risk management and connection to the patient, are critical. How many of your companies are doing this, or doing it right? Empowered operators don't act like naughty kids, going behind mom's back.  They understand why procedures are written as they are, and what can happen when they're not followed.


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