Implications and opportunities of applying QbD principles 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 for analytical methods. The authors present two concepts that have been created to improve robustness and facilitate continuous improvement m analytical methods and hope that the paper will stimulate further discussion regarding the application of QbD to analytical methods.