BA Sciences provides pharmaceutical method validation under cGMP, following USP and ICH Q2 (R1) guidelines. We can utilize the client’s protocol, or author a custom BA Sciences protocol. We also can develop the method at BA Sciences, or We can test the performance characteristics of the method including specificity, linearity, range, precision/repeatability, intermediate precision, accuracy, solution stability, limit of detection, limit of quantification, and robustness as required by the client during analytical method validation. BA Sciences has experience performing phase-appropriate method validation as needed for the current phase of drug product development.
Pharmaceutical method validation is required to demonstrate the method provides accurate, reliable, and consistent data and is suitable for its intended use. BA Sciences provides a full validation report detailing the results, and summarizing the method tested and protocol used, the reagents and equipment, and the calculations performed. All work is documented in our LabWare LIMS™ system, utilizing electronic notebooks (ELN’s).
