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Ashwini Rajeshwar Adepu* and Vijaya Bhogale


Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. 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. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals.

Keywords: Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Critical Material Attributes (CMA), Critical Process Parameter (CPP), Design Space.

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