Quality by Design approach which emphasizes product and process understanding and process control, based on sound science and quality risk management has been recommended by regulatory agencies. Analytical QbD (AQbD) is used in the method development in analytical techniques like HPLC and UV Spectroscopy. The AQbD process involves the creation of a knowledge space, identification of the analytical target profile (ATP), and the use of statistical data, economics, planning, psychological and risk assessment tools. Analytical Target Profile (ATP) is equivalent to Quality Target Profile (QTTP) in process design and it identifies the selection of method requirements such as target analytes (product and impurities), categories for analytical techniques, and product specifications. Once ATP is postulated, Critical Quality Attributes (CQA) identification is done, and analytical method performance characteristics (AMPC) are determined. The article also discusses Design of Experiment (DoE) and utilization of Method development operable region (MODR) in the analytical method development stage. AQbD offers several benefits such as enhanced knowledge sharing, development of high-performance methods, efficient regulatory oversight, regulatory filing based on science and rationale and reduced resource utilization.
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