Implications and opportunities of applying the principles of QbD to analytical measurements

The benefits of adopting a Quality by Design approach to pharmaceutical products and processes are generally accepted by pharmaceutical manufacturers and regulatory agencies. To date, however, industry has focused primarily on product development activities with little emphasis on developing a QbD approach to analytical methods. The authors of this paper present two concepts that have been created to improve robustness and facilitation of continuous Improvement in analytical methods and hope that this paper will stimulate further discussion regarding the application of the QbD concept to analytical methods.