A review on quality by design (QbD) - Its significance and applications

Gangaraj Tejaswini

Abstract

The pharmaceutical Quality by Design (QbD) 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. The basic concept of QbD is “The Quality cannot be tested into the product, but it should be built into it.” Quality by design is a direct relation to Product performance. The review paper includes the development process of QbD, significance and various applications in the pharmaceutical industry1. The process includes the quality target product profile (QTTP), critical material attributes (CMAs), quality risk management (QRM), Design space, comprehensive control strategy, and finally lifecycle management. The importance of QbD design is that it offers various advantages over the traditional approaches for the testing and development of drug quality. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality products. Applications of QbD to pharmaceutical processes (formulation development), analytical development are briefly discussed using few examples. A harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to risk management and science should be built up leading to better quality medicines to patients.
Full Text: PDF