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Mohini S. Bodhane*, Mrunalini J. Renghe, Shivam S. Lale, Swapnil Kulkarni, Yogesh Patil


Quality by design (QbD) is the modern, systematic and holistic approach for pharmaceutical quality. It has become a best ever solution to both industry and FDA to apply a more scientific, risk based, proactive approach to pharmaceutical development. The Rational behind this paper is to discuss the new approach of QbD and its certain key elements. The origin of QbD is from three ICH guidelines ICH Q8, ICH Q9 and ICH Q10 guidelines. QbD is based on principle that “Quality cannot be tested into the product but should be built in by design.” The main aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. While applying QbD approach one needs to understand and define QTPP, CQA (CMA and CPP). This paper also gives a brief account of risk based assessment, development and implementation of control strategy, concept of design space. QbD tries to find the root cause of failure and monitor it throughout manufacturing so that quality product is achieved. It is a beneficial approach for industry from both time and economic point of view over the current QbT approach.

Keywords: QbD, QTPP, CQA, Design Space, Control strategy.

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