QUALITY BY DESIGN (QbD) IN API

The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. The QbD based method development helps in generating a design space and operating space with knowledge of all method performance characteristics and limitations and successful method robustness within the operating space. A very useful component of QbD is the understanding of factors and their interaction effects by a desired set of experiments. For the purpose of QbD for HPLC methods, robustness and ruggedness should be verified early in the method development stage to ensure method performance over the lifetime of the product. Quality-by-Design principles are applied to build in a more scientific and risk-based multi-factorial approach to the development and validation of analytical methods using HPLC.