ABSTRACT

Quality by Design (QbD) is a systematic, scientific, holistic and proactive approach that begins with pre-defined objectives and emphasis on product, process understanding and process control. It essentially necessitates designing and developing the product and the manufacturing process to achieve the predefined product quality objectives. QbD identifies characteristics that are vital to quality from the patient’s point of view and converts them into critical quality attributes (CQAs) that the product should possess. Further, it establishes the limits, the design space, for critical process parameters (CPPs) and critical material attributes (CMAs) that affect the CQAs within which the process will be unaffected and consistently manufacture the desired product. This knowledge is then used to implement a flexible and robust manufacturing process that can adapt and yield a stable product. Risk assessment tools and design of experiments (DoE) are its integral components. This article gives a road map for successful implementation of QbD for pharmaceutical products.