Quality by Design Advantages Explained

Two Recipharm staffers say a quality by design (QbD) approach to drug manufacturing “will become of greater importance as forward-thinking companies look to boost their production capabilities, reduce throughput times, and adopt more continuous manufacturing processes.” Writing in a Pharma Manufacturing online post, the authors say QbD “uses a data-driven approach to deliver a better understanding of manufacturing processes, reduced likelihood of batch failures, more efficient and effective control of change, and greater return on investment, time, and cost savings. As regulatory authorities begin to demand that manufacturers design quality into products at every stage of development and manufacture, the use of QbD will become increasingly critical.”

The article looks at QbD advantages in terms of continuous improvement, change control, failure prevention, consistency, right first time, and reduced controls.