Analytical Quality by Design in Pharmaceutical Method Validation

Review article

Abstract

Analytical Quality by Design is an application derived from the principles of Quality by Design, it is mainly applicable for developing the analytical method for the pharmaceutical formulation. The method can be developed by without wasting time and solvents and saving time, by the application theoretical and practical experience and the serious of steps shall be followed such as, Analytical Target Profile (ATP), Critical Quality Attributes (CQA), Risk Assessment, Method Optimization and Development with DoE, Method Operable Design Region (MODR), Control Strategy and Risk Assessment, AQbD Method Validation and Continuous Monitoring of Method for fixing the drug or formulation to be analysed, which method is going to applicable for analysing formulation, risk associated with the method, fixing the range for the method, control the risk associated with the method, validation of method and monitoring the method respectively. If any risk found, the process will starts again to develop the reproducible method, hence it is a cyclic process. It is a systemic process for developing analytical method. Hence, it a valuable tool in the development of pharmaceutical analytical method