FDA Inspection Preparation: SOPs, Process Maps, And Gap Analysis

By David Butcher, MasterControl

The best way to pass an inspection conducted by the U.S. Food and Drug Administration (FDA) is to prepare for one, and the best way to prepare for one is to always be ready for one. With proper preparation and the right tools, a manufacturing organization can always be ready to pass an FDA inspection relatively stress-free.

During an inspection, a facility must be able to demonstrate that it is in a state of control. It may do so by having a quality system in place, understanding FDA expectations, and monitoring these systems. But no matter how compliant a quality system is, if the manufacturer cannot sufficiently show and prove it, the agency will not get the message. In the eyes of the FDA, if an activity or event that is not clear and documented, it didn’t happen.

Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

Process mapping and gap analysis can help clearly demonstrate and communicate one's quality system. Together they can show an FDA inspector how a system works as well as identify compliance issues internally well before the FDA arrives.