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October 2011

Holly Scott

What to Expect When They're Inspecting - Part I

by Holly Scott
Biologics Consulting Group, Senior Consultant, and Former CBER Consumer Safety Officer and FDA Field Investigator

The next time you attend an industry function like BIO, BioEast or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

One expects variations in the level of coverage at firms in different program areas, whether it's drugs, devices, biologics, dietary supplements, clinical research, or a food firm, because each industry area is so technically diverse. However, observation methods used by Investigators should be comparable and not diverge significantly. If two firms are manufacturing the same regulated product, and are both undergoing a routine GMP inspection, why does one receive an FDA-483 citation for an observation while the second firm receives no citation although the same observation was made? Is it a lack of continuity between Investigators, or are there other contributing factors?

The conclusion of an inspection can often be impacted by the level of firmness that officials are willing to demonstrate during inspections. This level of firmness can make the difference between receiving an FDA-483 or not receiving the same. You might say that these are the unwritten "rules" of an inspection. So, here is an interesting question: What are some of the non-GMP variables that can influence inspection results and how should you approach inspections with the purpose of improving inspection outcomes?

First, understand who is inspecting you. For example, consider the following: An FDA Field Investigator is the individual who is most likely to perform your inspection. "Inspector" is not their title, though there are many who refer to them as such, since conducting inspections is only one of their many professional duties. A "real" FDA Inspector (i.e, someone who actually holds the title of "Inspector") is a different individual altogether and is employed mainly in the area of Imports. In the case of a Pre-approval or Pre-license inspection, a firm can expect an inspection team comprised of a Field Investigator, a Reviewer from one of the Centers and the possible arrival of chemists, microbiologists, analysts, and/or any other individual with relevant product development, assay-methods, pharmtox, or process expertise. An FDA Field Investigator manifests his or her expertise during the enforcement of GMP regulations, due-diligence actions, document and procedure reviews, and compliance actions. They're also generally (and annoyingly) very good at finding those isolated—but significant—deviations that no one else seems to have noticed. With Field Investigators, you can expect their team approach to be very comprehensive.

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