The process of method validation involves several steps:
Define the Scope: Clearly outline the purpose of the method and the specific parameters that need to be validated. Develop a Validation Plan: Create a detailed plan that includes the validation parameters, acceptance criteria, and experimental design. Conduct Experiments: Perform the necessary experiments to assess each validation parameter. This may include calibration curves, spiking experiments, and repeatability tests. Analyze Data: Evaluate the data obtained from the experiments to determine if the method meets the predefined criteria. Document Results: Compile a comprehensive validation report that includes all experimental data, analyses, and conclusions. Continuous Monitoring: Regularly review and revalidate the method as needed to ensure ongoing reliability.
