A review on quality by design approach for analytical method development

Quality by Design (QbD) is a concept first outlined by well known quality expert Joseph M. Juran and it is a systematic approach to development that begins with predefined objectives and emphasizes product, process understanding and process control based on Echo knowledge and quality risk management. A conventional method may fail to meet the intended purpose during method development and validation.In a QbD approach, the impact and interactions between critical method variables are understood using a Design of Experiments (DOE) approach, which incorporates statistical multi-variate analysis and modeling leading to consistent quality of drug product. QbD tools like risk assessment and design of experiments, enable better quality to be incorporated into the analytical method, facilitate prior understanding and identification of variables affecting method performance. The main objective of the present review article to describe different steps involved in method development by QbD approach for an analytical method development. The QbD Approach for method development comprises of the following steps which include defining method intent, performing experimental design, evaluating experimental results and selecting final method conditions and performing risk assessment with robustness and ruggedness evaluation. The purpose of analytical QbD is to attain quality in measurement. The objective of this review article is therefore to provide a comprehensive understanding on various aspects of QbD, along with addressing the concerns related to its implementation.