Boston Analytical validates all methods under cGMP, following USP and ICH Q2 (R1) guidelines, using the client’s protocol, or using customized Boston Analytical protocols. We test the validation 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.
Validation is required by most pharmaceutical regulators to show the method provides accurate, reliable, and consistent data and is suitable for its intended use. Boston Analytical 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. Boston Analytical can help you validate your methods to prove they are fully viable.
- Customized Validation Protocol Development, including Development of Validation Acceptance Criteria
- Validation using USP <1225>, “Validation of Compendial Procedures”
- Stability Indicating Testing
- Forced Degradation Studies
- Transfer-ready Validated Methods Appropriate for the Phase of Development
- Revalidation when the method is updated, new compounds are analyzed, or the sample matrix changes