A. Many reviews of regulatory inspection activities focus on the top 10 citations/findings, which say a lot about the areas of concern, but little about how these inspections are conducted or whether or not inspections are getting tougher. Several agencies publish their inspection standard operating procedures (SOPs) or how they inspect (1, 2). This gives the industry a good idea how the inspection will be conducted and what areas will be looked at. The industry has studied these documents and learned from inspections over the years. Consequently, one should assume that all is well under control, but is it?
Feedback from both inspected companies and consulting firms points to a significant change in the focus of FDA inspections of foreign drug establishments and the expected response by the inspectors. This change has caught many companies by surprise. The following examples clarify the observed change:
Though the given examples resulted from US FDA inspections, there is no reason to believe other agencies do not or will not apply a similarly tough approach. In these and similar cases, the issue was that companies either failed to maintain their quality management system in a state of compliance with the applicable regulations and guidances, or that their attitude to resolving identified issues was neither holistic, nor investigative enough. This is a clear sign that there just is no room and time for complacency and failure to keep up with the developments in regulatory expectations. Just because inspectors sometimes provide industry with some leeway during inspections does not give them any right to flaunt the regulations and compromise compliance. Compliance really is an attitude, one that has to be understood, embraced, and implemented by everyone in the organization, including top management.