A Review on Quality by Design Approach for Analytical Method Development

Pharmaceutical

Quality by Design is the modern approach for quality of pharmaceuticals.Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design principles for in depth process understanding to ensure that product quality is built in by design.Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management. The purpose of this paper is to discuss the pharmaceutical quality by design and the main objective of the present review article is to describe different steps involved in method development by the QbD approach for analytical method development.In a QbD approach,the impact and interactions between critical method variables are understood using a Design of Experiments approach, multivariate analysis and modeling leading to the consistent quality by drug products.The QbD approach for method development comprises various steps that include defining method intent ,performing experimental design, evaluating experimental results,selecting proper method conditions,and performing risk assessment with changing analytical parameters and conditions for evaluation.

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.