FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
An FDA regulatory inspection is an activity of verification. It serves to give the FDA the assurance that your manufacturing processes are in control. The main factor in this is your ability to communicate that you have an effective, in-control quality system. This is where you can really use process mapping to your advantage. These maps provide an effective visual way of showing an investigator how a system operates. Internally, process maps will pinpoint your compliance hot-spots or gaps before the FDA sees them. FDA leadership often states that manufacturers need to have the proper systems in place. They also need to be able to show that those systems are in place and show that they are effective. Joseph Pickett of Expert Briefings explains that there are few better ways to show effectiveness than with good process mapping.