In order to provide cost-effective solutions to our clients we examine the validation parameters at the development stage to ensure that the method is scientifically sound and delivers the required results. JPL’s method validation service establishes that the performance characteristics of an analytical method are suitable for the intended purpose.
Validations are performed under a GMP environment. Unless otherwise required by our clients, we formally validate our methods as per ICH Q2 guidelines (International Conference on Harmonization), which includes; Accuracy, Method Precision, Intermediate Precision, Specificity/Selectivity, Limit of detection, Limit of Quantitation, Linearity, Range, Robustness, Filter Study, and Solution Stability, etc. As requested during the development and validation of stability indicating methods, JPL can perform forced degradation studies on your drug substance or drug product to provide stability validation of the analytical procedures. Routine forced degradation is carried through the application of using acid, base, peroxide, heat, and light.
Protocols employed for validation can be provided by our client or written by JPL experienced technical staff using our in-house method validation templates. Upon completion, detailed procedure and results for all method validation projects are presented in a comprehensive report.
JPL frequently conducts method verifications for our clients, following USP guidelines. JPL provides a complete verification package, including protocol development, sample analysis, and a comprehensive report.