The Most important aspect of the gxp’s


What’s most important in GMP or GDP?


eople often ask me what the most important GMP or GDP aspect is. I used to answer these questions with: Risk Management is key and must be incorporated throughout the whole Quality Management System. Or, I would answer that they should never forget to add and implement effectiveness checks within CAPA management.

During the years, as a manager however, I’ve come to realize that no matter how good your Quality Management System is, it will never be in optimal shape unless you have real senior management involvement, with senior management taking their responsibilities.

Senior management involvement must be a part of the company’s culture.

When you’re reading the 483’s and warning letters by the U.S. FDA it becomes clear that senior management is usually not aware of what happens on the work floor. Or, senior management knows but let’s it happen anyway.

A large number of the 483 observations is related to senior management involvement, being insufficiently involved. The question is; what should senior management be involved in then? Well, that’s simple: senior management in a GxP environment must be involved with everything that happens. In short; senior management must have adequate Quality Oversight.

Some managers think that micromanaging or fire fighting is the answer to the GMP/GDP management involvement requirements. And sometimes it is! But only when things go wrong. Creating a culture where employees are allowed to have and take responsibility will have a tremendous effect on quality improvement.

Even with new employees, new processes, or during a crisis; taking responsibility as a manager to be involved in what happens and to support employees in taking their responsibilities will make a huge difference in patient safety, having thorough Quality Oversight and being in control.

About the author

Peter van Doornik

Add Comment