Analytical methods used for the analytical determination of pharmaceutical impurities in drug products such as additives or stabilizers that have leached from drug device container closures are typically either quantitative methods or limit tests. As per the requirements of ICH Q2(R1), one would typically validate accuracy, precision, specificity, LOQ, linearity, and range for quantitative methods and for a limit test we would validate LOD and specificity.

However, including robustness as a parameter in the method development as well as performing a pre-validation by checking other parameters like precision, linearity, and so on enables you to take a more sustainable approach to the validation of the method. A robustness study can provide information of critical parameters that affect the method if not properly controlled and allow informed setting of system suitability parameters later on. With a robust method, there is a typically reduced need for further development work and demands on staff/instrument time leading to a faster more efficient method validation.

In this webinar, our expert Dr. J Susanne Becker, describes, with case studies, how sustainable approaches in analytical method development for drug products and drug product devices can be achieved.

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