
Society
Reimagining Quality Control in Prescription Drug Manufacturing
The FDA faces challenges in overseeing the quality of drugs, especially in foreign facilities. Improvements such as unannounced inspections, increased frequency of inspections, and alternative monitoring tools are proposed. It is suggested that importers designate a qualified individual in the U.S. to certify compliance with Good Manufacturing Practices (GMP) to strengthen the U.S. drug quality control system.