Quality by Design (QBD) and analytical methods

Quality by Design (QBD) and analytical methods have come into focus because of an inherent limitation in the guideline used for validation of analytical methods. The International Conference on Harmonization (ICH)’s Q2 guideline, Validation of Analytical Procedures: Text and Methodology serves as the guiding document for validation of analytical methods for pharmaceutical products. Since the […]

QBD in Analytical Method Development

QBD in Analytical Method Development QBD stands for Quality by Design. ICH Q8 (R), Step 2 defines QBD as “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. QBD in analytical method development is an important component, […]