At some point on your journey to an approved drug, biologic, or medical device, you (and any contract organizations you’ve hired to help you with nonclinical, GLP, and clinical studies as well as manufacturing) will be subject to inspection by the regulatory authorities with whom you plan to file your application. The inspections help your review committee ensure that the drug or device is safe and effective for patient use. Depending on your regulatory strategy, you may have inspectors from more than 1 agency; however, we’ll focus on FDA inspections in this post. What inspectors look for may seem mysterious, but the process follows specific instructions established by the agency in the Compliance Program Guidance Manual. The freely available manuals for each program are an invaluable reference to the specific policies, programs, and procedures the inspectors expect to see, and you should plan on careful review of the relevant manuals when preparing for your inspections. For example, sterile drug process inspections are covered under compliance program 7356.002A, drug pre-approval inspections under program 7346.832, and device premarket approval and postmarket inspections under program 7383.001. Don’t wait until after your filing to review the relevant guidance manuals – they can be very helpful during the vendor selection process and while preparing your application.

Text Copyright © 2019 Katrina Rogers