Introduction to Quality by Design

The pharmaceutical sector is concerned with product efficacy, safety, and quality. FDA decided to implement various Designs of Experiments (DoE) in the pharmaceutical industries. Quality by Design helps in the development of high-quality products and guides to manage product quality across its entire life cycle. This method quickly gains popularity worldwide due to its many benefits and use of numerous high-quality statistical tools. QbD is a meticulous, proactive, risk-based strategy for pharmaceutical development that commences with predetermined goals and emphasizes product and process understanding and process control based on reliable research. The QTPP, knowledge of product and process design, scale-up, control strategy, and constant improvement are considered as crucial components of pharmaceutical QbD. After approval, during the product lifecycle management process, the competency of the product and the process is evaluated and continuously enhanced.