DOI: 10.21276/sajp.2018.7.6.8

Pages: 260-265

This article describes the concept of pharmaceutical Quality by Design (QbD) and how it can be used to ensure pharmaceutical quality. QbD is a significant part of the present-day approach to improving pharmaceutical quality. It can be described as a novel approach to development of any product which may increase efficiencies, offer regulatory relief and pliability, and also provide business advantages throughout the product lifecycle. In the present review, basics of QbD along with its regulatory needs are discussed. For the detailed explanation of how QbD ensures the drug product quality, several documents from ICH such as ICH Q8, i.e. Pharmaceutical development; ICH Q9, i.e. Quality Risk Management; ICH Q10, i.e. Pharmaceutical Quality Systems and FDA’s Process Analytical Technology (PAT) were referred. By using QbD, formulation and manufacturing variables can be appropriately understood and controlled.