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Building Green Pharmaceutical Manufacturing on a Foundation of PAT and QbD
Although they began on different paths, the Principles of Green Chemistry and Engineering share plenty of common ground with the Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives. Full process optimization must take a holistic view of health, safety, environment and economic concerns; and applying the principles of Quality by Design (QbD) and Process Analytical Technology (PAT) to the design of a robust pharmaceutical manufacturing process should result in improvements in process efficiency, process consistency, and product quality. The application of QbD builds a higher level of process understanding to facilitate the robust design and scale-up of optimized processes. The application of PAT enables the monitoring and control of manufacturing processes to minimize wasted time, energy and raw materials – assuring product quality while improving overall production throughput and profitability. Although the QbD and PAT efforts extend beyond a goal of safe and sustainable manufacturing, many of their objectives are in complete agreement with select principles of Green Engineering which emphasize maximizing efficiency, preventing waste (rather than treating it), and reduction of energy consumption.
Paul Thomas was the Senior Editor of Pharmaceutical Manufacturing magazine, Pharmamanufacturing.com, and PharmaQbD.com.