Abstract
Over the past decade, there has been progress in the adoption of systematic science and risk approaches for pharmaceutical development, which emphasize product and process understanding, as well as control strategy. Nevertheless, available product quality data show that pharmaceutical manufacturing and its regulation, in general, are being confronted with new and increasingly complex challenges, such as unacceptably high occurrence of product recalls and drug shortages. The adoption of emerging technology is one of the key mechanisms for addressing these challenges. Continuous pharmaceutical manufacturing is an emerging technology that offers potential flexibility, quality, and economic advantages over batch processing, both in process development and manufacturing. Over the past decade, there have been significant advancements in science and engineering to support the implementation of continuous pharmaceutical manufacturing. These investments, along with the adoption of the quality-by-design paradigm for pharmaceutical development and the advancement of process analytical technology for designing, analyzing, and controlling manufacturing, have furthered the scientific and regulatory readiness for continuous manufacturing. Building on this progress, research efforts should continue in several key areas to address the remaining implementation challenges.
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