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MD Irshad Alam*, Nazia Khanam, Jalil K. Shaikh and Sovan Ganguly


The main objective of the present review article is to understand the concept of pharmaceutical Quality by Design (QbD) and discuss its application and implementation to ensure pharmaceutical quality & drug development. As it is known that pharmaceutical industries are constantly searching for different ways to ensure and improve product safety, quality and efficacy, regulatory bodies are therefore concentrating on implementing QbD, a science based approach that improves process understanding and enables process-control strategies. This new approach to drug development could increase efficiencies, provide regulatory relief and flexibility and offer important business benefits throughout the product’s life cycle. Under this concept of QbD during designing and development of a product, a company needs to define Target product Profile (TPP), identify critical quality attributed (CQA) and Quality risk management (QRM). The pharmaceutical industry that follows QbD norms designs the product formulation and process to meet the product attributes, as results of all obtained details the company can continually monitor and update its manufacturing process to assure consistent product quality.

Keywords: Quality by Design (QbD), Quality target product pr

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