I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation as anything else.
I have divided companies with significant regulatory issues into two categories: those who seriously strive to make the connection between the purpose and intent of the regulations and weave it into their business values; and those—well, those who see the FDA regulations as bureaucracy that encumbers its business with burdensome rules.
The former eventually agrees that CGMPs are a business enabler, since they support the mutual goal of safe and effective drugs that meet important public needs. The latter is frustrated that CGMPs seem to get in the way with its legalistic investigation and documentation when things do not go as expected.
The former eventually sees company policies and procedures as intent of the company to control the human variable by doing work the best possible way to achieve a predictable outcome. The latter sees policies and procedures as restrictive to their ability to ad lib when situations call for flexible ways of working when faced with the unexpected.
The former sees the quality management system as the means to assure product down to the unit when sampling and testing could never be of sufficient size to provide that level of assurance. The latter considers it a success when all the final product test results are met—or rationalized—and that there are no bodies lying in the street.
The former sees CGMPs as a supporting consistent, reliable manufacturing and continuous product supply to its patients. The latter scoffs at CGMPs saying, “Don’t you understand? We have medically necessary products. We have to find a way to release this lot.”
Culture starts at the top. The behavior of company senior leadership sets the tone for whether the culture embraces or is antagonistic toward the U.S. Food and Drug Cosmetic Act and the Current Good Manufacturing Practices—the price of admission into this business.
The company that applies these regulations in the spirit and intent, as well as efficiently and effectively as possible—will have the most economical control of quality, and will have a competitive advantage.
So in the end, how will you know when the culture has favorably changed? It will be when everyone—top to bottom—becomes self-correcting. When one sees another doing something out of compliance, he/she says: “We don’t do it that way here.”
