An Overview on Quality by Design

Abstract

Quality by Design (QbD) has as a new concept for the development of high-quality pharmaceutical products. It is an essential component of the modern approach to pharmaceutical quality. QbD is the best way to build quality into all pharmaceutical products, but it poses a significant challenge to the pharmaceutical industry, whose processes are time-bound, despite inherent process and material variability. Throughout the design and development of a product, it is critical to define the desired product performance profile [Target Product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed to the product (CQA). Applications of QbD to pharmaceutical processes (formulation development) and analytical development are briefly discussed. A standardized pharmaceutical quality system that is applicable throughout the product's lifecycle and emphasizes an integrated approach to risk management and science should be developed, resulting in better quality medicines for patients.ICH documents 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 to in order to ensure drug product quality. QbD allows formulation and manufacturing variables to be properly understood and controlled.