Compliance problems start at the top

When the issue of FDA compliance is bandied around a table, it's impossible to steer clear of the argument that a company's “culture” starts at the top and always trickles down. The pharmaceutical industry, forever looking over its shoulder at the FDA, will never be able to escape from this axiom.

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How is this being addressed? There are changes afoot in the corner offices of the world's leading pharmaceutical manufacturers, change that has been driven in part by the FDA district offices and their steady muscle flexing. Some of the world's biggest corporate names have been hit where it hurts the most, in the wallet, and are now digging their way out of public relations “situations” by establishing tighter quality policies and empowering internal quality-control groups.

Our sources tell us that these efforts are being made to increase the lines of communication between the FDA and the manufacturers that will eventually lead to better understanding of the regulations and guidelines; in turn, assuring that mission-critical documents match up with the company's own cGMPs nearly guaranteeing compliance. Of course, rare are the times when this good news, these positive moves, get the print they deserve.

I realize this may sound a little textbook, but it's this practical approach to relationship building that will work best for pharma's continued success. And it was just this kind of approach that the Parenteral Drug Association (PDA) took in much of its conference programming at this year's annual meeting in Washington, DC.

Hats off to Michael Beatrice, Abbott's vice president of corporate regulatory and quality science, who, during his opening plenary session, presented a very frank discussion on the healthcare giant's new processes that have, in effect, started from the top down. It was refreshing to actually hear to some “real-life” examples and situations that are helping this major player dance on the edge of “sate-of-the-art quality.”

It's often quite difficult to get the inside story on standard practices and procedures; themes that weigh heavy on the minds of many of our readers. While those living examples are essential to fulfilling our editorial mission, they are all too often kept locked up as “proprietary.”

But here's something that rubbed off on me during my time mingling with readers at PDA's annual meeting that could help answer many of their compliance conundrums.

We so often forget just how crucial corporate culture can be in our processes. If you're a manager or do, in fact, occupy one of these offices, keeps this in mind: When your company is having a problem with the FDA it's a management problem. Take a good look at your culture and when there is a problem, ask yourself what you knew about it and when you knew about it. The rest should fall into place and maybe you'll find time to share the story of your corporate change.

Michael Levans
Chief Editor


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