FDA's global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
FDA Commissioner Scott Gottlieb, MD, said Wednesday the agency has released its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspection
FDA Commissioner Scott Gottlieb, MD, said Wednesday the agency has released its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections. The policy, he explained, takes of factors such as a facility's compliance history, recall trends, time since last inspection, and the inherent risk of the drug being made. Gottlieb noted the "large-scale endeavor" of FDA's inspections program, pointing to the more than 5,000 human pharmaceutical sites worldwide that were subject to routine surveillance inspection in fiscal year 2017, including 3,025 that were foreign-based. In that year, he said, FDA conducted a total of 1,453 drug surveillance inspections, including more than 760 in other countries, to make sure the companies were following Current Good Manufacturing Practice requirements and maintaining high standards of quality. "In addition to identifying the facilities of greatest risk and prioritizing those inspections, the FDA has also made efforts to ensure our resources are effectively deployed to address inspection demands," said Gottlieb. He also noted FDA recently updated its inspections classifications database, which includes the most recent classifications of inspections of manufacturing sites conducted for routine CGMP surveillance purposes or inspections of sites conducting bioequivalence/bioavailability studies.