Rockville, MD (Apr. 28)-To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration’s Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.
Margaret Glavin, associate commissioner for regulatory affairs, told ORA employees in an internal agency memorandum (according to Drug Industry Daily) “the focus of CDER over the next five years is to increase the number of inspections based on anticipated advances in manufacturing technologies. We must ensure that we have the proper analytical disciplines, equipment, and processes in place.”
Additional inspections are anticipated as industry and various organizations announce support for the proposed Globalization Act (currently in draft), which would require FDA to inspect all overseas drug-manufacturing plants once every two years instead of continuing its current risk-based approach.
