A compliance officer recalls an unguarded moment at a very public event when a consent decree is announced.
It finally happened. The FDAs patience with our companys lack of dedication to cGMP compliance expired. The verbal warnings that inspection teams started to give us over six years ago for several of our manufacturing plants did not get the attention of senior management. Then we started getting warning letters for ongoing failure to adequately follow cGMP requirements and expectations. Now, weve just been notified of a consent decree and the biggest fine in pharmaceutical industry history. I use to work in several of these manufacturing facilities before bailing out for a position in corporate quality compliance. We use to have a good reputation for compliant manufacturing and quality control. I hate to point fingers, but our company started on a strategy of rapidly acquiring other product lines about eight years ago. Weve been attempting to merge four different organizations and compliance cultures ever since. No matter what the senior executives say to the press or shareholders, were still living with some difficult situations in manufacturing and quality operations. Its no wonder the FDA got fed up and banged us over the head. I mean, when you find repeated and ongoing violations in such basic areas of GMP compliance as documentation (employees signing off on records for work they did not perform or were qualified) or staffing (some manufacturing areas shared supervisors just fresh out of school) or investigations (where do you want to start?) or quality control lab operations (lack of validated methods), then youve got to sit up and take notice. But because weve been so successful for so long, we thought we knew better than the FDA and resisted making any real changes to our QA, QC, and manufacturing systems. I mean it wasnt like plant management or corporate executives didnt have findings from internal quality auditors pointing out these issues. Maybe it had something to do with the incessant arguments and furious (sometimes personal) debates that took place over these findings versus just getting on with improving regulatory compliance. I wish we had stood up a little more independently as the quality unit and enforced compliance with these basic, common sense procedures. No doubt we missed an opportunity to avoid this crisis. So, I hope we can respond to the FDA body blow. Itll take a lot to change our work environment around here. For example, at the satellite broadcast for the consent decree announcement, one of the vice presidents of manufacturing (I wont tell you which division) made a statement when he thought his microphone was turned off. Just 10 minutes before the CEO of the company came on, he said in a frustrated tone of voice: Lets get this over with so we can go back to makin product. I was sitting with a group of people from several different departments when we heard that. One person looked at me and asked if I had heard what he heard. You can imagine how the story has circulated through this corporate grapevine. So, wish our company luck in meeting consent decree commitments. I think well need it.
