Authors: Devanshi Upadhyay, Damini Vadnerkar, Prof. Mitali Dalwadi, Dr. Chainesh Shah, nDr. Umesh Upadhyay
Abstract: Quality-by-design (QbD) may be a systematic approach to drug development, which begins with predefined objectives, and uses science and risk management approaches to realize product and process understanding and ultimately process control? The concept of QbDare often extended to analytical methods. The emphasis of AQbD approach is on understanding of the operation and the variables affecting Analytical Methods employed in product development and hence creating an extensive knowledge repository. The variables which affect the output are identified and subjected to thorough risk assessment employing various tools and techniques discussed within the article, after which the variables are optimized. The final method is validated and a control strategy is put in place. Additionally, global harmonization of QbD terms and explicit guidelines on implementation of the QbD approach in all fields of product development including Analytical Techniques is necessary to streamline the path towards embracing this unique and effective approach.
Keywords: Quality, Quality by Design, Analytical QbD, Method Operable Design Region (MODR.
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