BA Sciences provides pharmaceutical method validation under cGMP, following USP and ICH Q2 (R1) guidelines, using the client’s protocol, or using customized BA Sciences protocols. We test the performance characteristics of specificity, linearity and range, precision, accuracy, solution stability, limit of detection, limit of quantification, and robustness, and other parameters, as required by the client during analytical method validation.
Pharmaceutical method validation is required by most regulators to show the method provides accurate, reliable, and consistent data and is suitable for its intended use. BA Sciences provides a report clearly detailing the results, as well as citing the method tested and protocol used, the reagents and equipment, the calculations performed, and the procedures followed. Since results are collected using a LabWare LIMS™ system, details are available in ELN format. BA Sciences can provide pharmaceutical method validation services to validate your methods and prove they are fully viable.