Tag: quality

Common terms used in USFDA Inspections


Types of USFDA inspections. Pre-approval/Application-based inspection = conducted before the USFDA approves a new drug, biologic, or medical device for marketing in the US. Routine/GMP/Surveillance/Post marketing inspection = conducted periodically to ensure that the manufacturing facilities and processes continue to comply with cGMP regulations. Compliance follow-up = conducted to verify that a facility has taken … Continue reading Common terms used in USFDA Inspections