Is Noncompliance Just Human Nature?

There were lots of subtle and not-so-subtle messages about industry's failure to comply with basic GMPs brought up during the PDA-FDA joint regulatory conference last month in Washington, DC. FDA speakers made it clear that the most common GMP inspection citations have not changed much in the past decade, suggesting that industry has not yet gotten its act together. Most observations found by inspectors continue to be tied to the quality control unit and overall deficiencies in quality management systems. And as we have learned during the past few months, these types of deficiencies can lead to drug recalls and ultimately, drug shortages, a major public-health concern.

Angie Drakulich

A few conference participants brought up the notion that "to comply" is to go against human nature. It's much more natural, they suggested, to try and hide a mistake or to rely on one's own opinions about how things ought to be done, as opposed to following a set of rules. It's not so much defiance that is causing quality problems, however, as is a lack of training, they added. For example, if someone in the testing department does not understand why he cannot walk into a sterile room with regular shoes on, why would he make a big deal out of doing so? In many cases, employees just don't understand why certain procedures must be followed and what the consequences are for not doing so. One FDA speaker pointed to a small company of 10 employees that was recently found to have not undergone any GMP training.

So the larger elephant in the conference room was the fact that industry senior management needs to take a more proactive role in understanding and explaining quality GMPs and risk-based approaches to all employees, at all sites. The patient—rather than the bottom line—must be in the minds and goals of management at all times in order for a sense of ownership and responsibility to trickle down. One audience member even suggested renaming Good Manufacturing Practice to be Good Management Practice. I expect we'll hear more on this topic in the future.

Angie Drakulich is the senior managing editor of Pharmaceutical Technology.