QbD is a systematic approach to pharmaceutical drug manufacturing development. QbD is built on a deeper understanding of the causes and effects of variability in the manufacturing process. This understanding is based on sound science and risk management.

Without QbD, quality must be “inspected in” to a product at the end of the manufacturing cycle. With QbD, the factors that contribute to an approvable, quality product are understood up front. This enables the manufacturing team to quickly address any source of risk, resulting in higher assurance of product quality and additional opportunities for manufacturing efficiency and flexibility.

While the initial investment is higher, QbD reduces costs through the life cycle of the product. QbD is a growing trend, and regulatory agencies expect that more products will be developed using QbD. Sufficient details of development and manufacturing information must included in regulatory submissions.

QbD incorporates FDA regulatory guidances, including ICH Q8, Q9, Q10.