I retired from the FDA about one year ago this summer. I have mixed feelings about my twenty-one years with the Agency, but I mostly reflect back on the good memories and the great people I had the pleasure to learn from and work alongside. I find myself pivoting to my second curve, as popularized […]
No, please don’t. Environmental Monitoring (EM) program is not a “one size fits all” package. Rather, it should be customized to a particular manufacturing space and the processes used after a robust risk assessment that considers potential failure modes and then followed up, periodically evaluating past EM data. If you were to do an internet […]
A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)). Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022. This document is […]
