Since the FDA released its current good manufacturing practices (cGMPs) and 21st century initiative that includes promoting industry modernization, the majority of industries—including pharma—have gotten onboard the digitalization and Industry 4.0 train. Though cost and documentation hold some companies back, this has resulted in improvements such as robotics and biometrics initiatives in drug product manufacturing being implemented as well as the adoption of modern, robust aseptic processing technologies that afford tangible safety benefits to sterile products. Three industry panelists and a U.S. FDA regulatory expert presented on these subjects at the 2021 PDA/FDA Joint Regulatory Conference:
James C. Weber, advisor IT, digital manufacturing, Eli Lilly and Company
