Being proactive is always better than being reactive. And when it comes to a possible “visit” from FDA, anticipation and preparation go a long way in lowering anxiety and navigating the process successfully.
Knock, knock. When an FDA investigator walks into your facility informing that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Reaching out at that moment to your employees to inform them of the presence of the FDA at the facility is a common occurrence so that they are prepared to face the investigator or a team of investigators. However, being prepared all the time for such a moment can calm the nerves and facilitate the interactions.
Ready. Set. Read “FDA Inspection Preparation.” Authored by Tamil Arasu, Principal Consultant, Lachman Consultant Services, Inc. the article highlights the types of FDA inspections that are conducted at a pharmaceutical facility focusing on drugs. Generally, the Office of Regulatory Affairs (ORA) conducts the inspections, however, it is not uncommon for the Center for Drug Evaluation and Research (CDER) personnel to join or independently conduct FDA inspections, particularly during Pre-approval Inspections. This article prepares you for these circumstances and provides a comprehensive overview of the types of FDA inspection, what to expect, and the steps to accomplish before, during, and after.
