Quality by Design (QbD) is a strategic process for development and manufacturing. It is meant to ensure that the intended performance of a final drug product is as expected – both in terms of purity and efficacy. To achieve this requires well-described objectives, and proper risk management.
Quality by Design includes a thorough understanding of the technical process, the variables that affect the process and the performance envelope in which those variables remain in order to achieve the objectives. The advantages of QbD benefit both the consumer (since the product will be consistently safe and effective) and the manufacturer (since quality and costs will be well understood, controlled and predictable).