Airflow visualization studies (AVS) (also known as smoke studies) are an integral part of contamination control practices in GMP-controlled aseptic processing plants. As per regulatory guidelines such as the FDA’s 2004 Guidance on Aseptic Processing (here), USP <1116> (here), and PDA Technical Reports 13 (here), 22 (here), and 34 (here), these studies enable the measurement […]
As you will all be aware, EU GMP Volume 4 Annex 1 and PIC/S Annex 1 (hereinafter referred to Annex 1) for “the manufacture of sterile medicinal products” was published in August 2022 and the majority of the guidance came into force in August 2023. One of the key elements of the guidance was the introduction of Quality […]
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 […]
