Robust And Flexible Analytical Method Development Through Quality By Design: A Review

Abstract

Application of Quality by Design for analytical method development resulted into a method having robustness and ruggedness which  is complying with ICH quality guidelines. Quality by Design begins with determination of goal. Critical quality attributes directly affect the quality are to be sorted out first. The best way for method development is Analytical target profile which describes method requirements. In method design use of various flowcharts, decision tree can be made for correct implementation. Assessment of risks is a connection between input method factors and critical quality attributes. The data obtained from the experimental design should be studied by the usage of various statistical methods. Many software packages are available for assisting and performing statistical analysis, reporting the results and generating a mathematical model. The next step after the development of method through quality by design is method validation.