Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development

Abstract

Purpose : QbD is a helpful tool in building quality products and to understand critical process parameters which affects the manufacturing of drug products. It helps to build control strategy which helps to maintain quality throughout its life cycle. Approaches : The major approach in QbD is through DOE which includes either screening or optimization done by various designs like plackett-Burmann, Box-Behnken design, Fractional Factorial design, Central Composite design, Mixture design etc. Findings : QbD approach helps in formulating and maintaining quality in the drug product. It helps to identify the critical quality attributes and process parameters which are likely to affect the quality of the drug product through screening design. Conclusions : Adopting QbD concepts into manufacturing of the drug product has its advantage of reducing development and marketing costs. It also helps in meeting regulatory requirements.