Article of interest_Applying Quality by Design (QbD) principles to the development of analytical methods
Narendra Kumar, Assistant Professor Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education& Research Hyderabad, India writes about the application of Quality by design (QbD) principles to the development of analytical methods.
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Summary:
The article highlights the application of Quality by Design principles to the analytical (HPLC) method development process. A marriage of HPLC with QbD is suggested for rapid and robust method development, understanding factors influencing chromatography, easier transfer of the method through proper documentation. The use of various modelling software programmes allowed a limited amount of experimental data to be used to examine a large number of probable run conditions. Once the optimum run conditions and their tolerance to change were predicted, experiments were run to confirm the predictions. This data in the future can on the one hand serve as a common medium of discussion between analysts and regulatory bodies and easily and quickly diagnose any problems which may be encountered during the lifecycle of the method.
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