The pivotal role of human behavior in aseptic operations cannot be overstated, as it significantly influences the safety and efficacy of sterile drug products. This article delves into the incorporation of human factor principles as a proactive and strategic move, aiming to navigate the complexities inherent in aseptic operations and, in turn, ensure the steadfast safety and efficacy of sterile drug products. The approach systematically addresses human factors that may impact aseptic operations. First, organizations recognizing and accounting for the human element in the aseptic manufacturing process go a long way in initiating mitigation activities.
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