7. Quality by design: A holistic concept of building quality in pharmaceuticals

Quality by Design (QbD) refers to a holistic approach towards drug development. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. The concept promotes industry’s understanding of the product and manufacturing process starting with product development, basically building quality in, not testing it. Under this concept of QbD during designing and development of a product, a company needs to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). On the basis of the information company then design the product formulation and process to meet the product attributes. This leads to understand the impact of raw materials [critical material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control sources of variability. As results of all understanding, a company can continually monitor and update its manufacturing process to assure consistent product quality. This systematic approach to product development and manufacturing has received a great deal from traditional approach, which was extremely empirical. Implementation of QbD is enabling transformation of the chemistry, manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs) into a modern, science and risk based pharmaceutical quality assessment.