Bioassay Qualification and Validation

Once the assay is developed, assay validation or qualification is performed to confirm that it fits its intended purpose. Method qualification typically describes activities that demonstrate the suitability of a method for use in the early stages of drug development, while assay validation includes experiments to demonstrate that the method is reliable for long-term use in the late phases of drug development.

To meet all the specifications in the ICH and USP guidelines, we typically evaluate the performance of potency assays in terms of precision, specificity, accuracy, linearity, range, and robustness.

Assays to be qualified or validated are product-specific methods, and the scope of validation or qualification procedures depends on the phase of drug development.

Our QC Testing Services offer both qualification and validation of bioassays in a GMP-certified laboratory according to ICH and USP guidelines to ensure that the developed methods meet the performance criteria necessary for use in lot release and stability studies.