ANALYTICAL QUALITY by DESIGN – A REVIEW
Asmita Mahapatra, Subramania Nainar Meyyanathan · Indian Research Journal of Pharmacy and Science · 2020
Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle.These activities if properly not streamlined based on the knowledge of science and process understanding may lead to a very costly and time consuming procedure.Pharmaceutical industries are striving for new pol which can be added or replace the existing elements of quality and risk management system.expert Joseph M. Juran first outlined the concept of Quality by Design.(QbD).to analytical method development known as AQbD.begins with predefined objects and emphasises product and process understanding and process control.Quality by design is a vital part of the modern approach towards a method approach to drug development.The main ob involved in method development by AQbD approach for an analytical method development Performance Attributes), MODR (Method Operable Design Region), Analytical Method Validation, Control Strategy, Continual Method Improvement.