Quality by design (QbD) is an approach that aims to ensure the quality of medicines by employing risk management, experimental and statistical methodology in the design, development and manufacturing of medicines.

Quality by design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. QbD is a systematic and dynamic approach that assumes that quality is built in by design and is improved continuously.

The benefits of QbD are numerous. The most important is the fact that the use of QbD allows you to acquire a better understanding of the process and the product and in the determination of a more defined control strategy; enhancing regulatory confidence. Other derived advantages include, the possibility of a faster track development; reducing the timeline through to market approval, focused strategy for process validation and change control, improved quality evaluation and acceptance of out of specifications. On the whole, QbD provides a welcome and advantageous flexibility in terms of both industrial and regulatory aspects.