Accelerating Biopharmaceutical Virtual FATs in a Pandemic

Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches. Developing standardized factory acceptance test (FAT) execution approaches fit for the current times can allow for consistency across equipment vendors and their biopharmaceutical clients. This article describes pragmatic best practices that would support the momentum for new domestic manufacturing facilities.