Quality by Design: A New Era of Development of Quality in Pharmaceuticals

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. The purpose of this article is to discuss the concept of Quality by Design and describe how it can help to ensure pharmaceutical quality. QbD has to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. QbD uses a systematic approach to ensure quality by developing a thorough understanding of the compatibility of a finished product to all of the components and processes involved in manufacturing that product. Instead of relying on finished product testing alone, QbD provides insights upstream throughout the development process. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile i.e. Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognise the impact of raw materials [Critical Material Attributes (CMA)], Critical Process Parameters (CPP) on the CQAs and identification and control sources of variability. 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.