The ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2) and will be effective from June 14th, 2024. It includes some mandatory additions to each validation aspect and some discretionary changes, mostly focused on how to perform and evaluate the method set-up phase. This revision not only updates the approach to analytical method validation, but also sets new standards for precision, accuracy, and consistency in pharmaceutical analysis.
This webinar aims to provide practical application examples of method validation, according to the updated guidelines. Our experts will analyse and discuss the development and validation of an LC-MS method for the determination of nitrosamines, by detailing step by step the necessary evaluations to validate for each study parameter, according to the new mandatory requirements.
The discussed validation strategy, that will focus on implementing the actual changes, can be an overall application to all chromatographic techniques, without the need of dedicated instrumentation or specific software. The planned and further execution of the design of experiment, for method development of the analytical activity in accordance with ICH Q14, even if not mandatory will also be considered.