ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.