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Kapil Joshi*, Abhay Asthana, Subhash Pande, Gyati Shilakari Asthana, Kishan Singh and Garima Goomber


Quality is primary attribute to any industry and its products manufactured. Quality by design (QbD) and six sigma is the modern approach for pharmaceutical quality development and management. This paper gives an idea about the interrelationship between pharmaceutical QbD and six sigma and describes the use of both (QbD and six sigma) to ensure the quality of pharmaceuticals. The use of QbD and six sigma principles (using DMAIC and DMADV) during product development provide opportunities to facilitate innovation and continual improvement throughout the product lifecycle which can increase the efficiency of manufacturing processes; reduce the defects and product non-compliance, resulting in cost savings for pharmaceutical companies. QbD and six sigma can also be helpful for the use of innovative technologies and enhance the use of new approaches to perform process validation like continuous process verification. QbD is a systematic approach and has the potential to make a positive contribution towards drug development and six sigma is a project oriented, statistical approach for reducing variability, removing defects and eliminating waste from products and processes.

Keywords: Quality by Design, Six sigma, Critical Quality Attributes (CQAs), DMAIC (Define, Measure, Analyze, Improve, Control), DMADV (Define, Measure, Analyze, Design, Verify).

[Full Text Article]

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