Were you 7 years in the same role? Coincidentally, the active that I got patent for was a project that originated first and got sold off from P&G. You sound like you are in the Dayton-Cincinnati corridor. Did a little bit of exploratory work on a contracted basis at Girindus on this very project. Have utilzed services of a number of Cincinnati-based consultants in recent years.
The company was contracted to make the product. The lab manager and one of the technicians failed to document analyses as they were performed--the notebook pages were blank. When the product left the site, it was to be put into swallowable form, but otherwise was finished.... And this one routinely cut corners and had safety issues. One night the plant had a cyclohexane waterfall.
You are describing a complete failure of cGMP compliance. I must ask then, what did you do when you saw this? In your 30+ years of experience were you promoted to a mangerial role, and were you in one here? How long did you choose to stay working in this environment?
I'm 61 years old and I got my BS in 1972. How much more experience do I need to discern a trend? ... I have 30+ years of solid performance and making improvements wherever I go, yes, even at the most schlocky of operations. But I have seen very little interest in excellence. Quality gets lip service, but cutting corners is almost always operating.
A BS is a career starting point for many. Did you obtain higher education in a subject related to natural sciences or business, and, if not, why not?
In 30+ years what senior level experience have you had in that time? A firm's interest in establishing an environment which promotes excellence is a typically a reflection of its leadership. What leadership roles have you held in these 30+ years?
Carelessness might be seen as a trend in some firms, and that is typically corrected by better training and ovesight - sometimes a wholesale change in mangement. Malcious and fraudulent behavior is not the trend, as those who evidence such behaviors do not survive for long in today's consumer products industries.
As I say FDA doesn't always get it right about everything, but the reason the US drug supply is the gold standard of the world is because the US understands, and agressively enforces cGMP compliance. What you have described is not a general industry trend -- at least not in the US.
Have you ever asked youself how it is that in 30+ years you seem to find yourself working for predominantly schlocky operations?
FReegards!