Don’t Blame Your Quality Issues on FDA

Yet another GMP manufacturing disaster has been reported in the news. This time, a major player in the industry had several of its products seized from warehouses after failing to resolve two years worth of quality control issues. Manufacturing and distribution of these products “ representing over a billion dollars in sales - was halted until FDA regulators were satisfied the company had taken necessary steps to fully resolve problems found in previous inspections/warning letters. The response from the company placed blame on the FDA for failing to accurately communicate its expectations. As a former manufacturing executive and now GMP consultant to the industry, I hear this excuse too many times from the spin-doctors in corporate communications (and the legal counsel telling them what to disclose or not disclose to consumers or shareholders). From my perspective, there are four issues at work here: accountability, arrogance, awareness, and anticipation. Lets start with the easiest one “ its not about the FDA. Sure, theyve got their organizational problems, their bureaucratic politics, and their hopelessly conflicted missions. But, you and only you “ Corporate Decision Maker - can make decisions in your workplace which bring manufacturing processes and quality control systems into compliance. So, stop pointing fingers at the FDA. Look at yourself in the mirror and accept the accountability that comes with having an approved drug or biological product on the marketplace. Then, get serious about taking actions which both systematically and systemically solve the GMP problems youre experiencing. Next - get over your arrogance. If you think the FDA wont shut you down or make life miserable for you, think again. Yeah, you may have the only product on the market “ for awhile, but that doesnt mean the agency wont use its power to get your corporate thinking and behavior back in line. I know of a former company president who admitted that the FDA had effectively shut one of his operations down for six months after years of contentious discussions and poor relations. He said his ego and aggressiveness cost the company over $300 million in lost sales as a result. Moving to the next issue “ raise your awareness about GMPs. You need to get yourself informed and educated about GMP expectations. When I say expectations, its not just Parts 210 or 211 or 600. Its not solely about your own corporate policy and procedures, although I see lots of corporate decision makers ignorant about their own SOPs and protocols. Its the whole body of decisions, guidelines, best practices, and directives that come out of the Food and Drug Administration and their counterparts in Canada and Europe. Finally, Ive got to say something about unintended consequences. Enlarge your thinking to consider what the positive and negative implications of your decisions are going to be “ whether you decide to take action or whether you decide not to act. Its like the ripples in a pond when you throw a stone into it. In the tightly controlled world of GMP manufacturing, its never the first ripple that negatively impacts your operation or organization. If you start to anticipate what might or could happen, then youll make better decisions. And those decisions may prevent you from becoming the next GMP manufacturing disaster