Must USP Methods be Validated? There is no general requirement that USP methods be validated since they were successfully validated prior to their inclusion within the USP. ... USP methods, and Compendial methods in general (e.g., BP, and EP) must be verified.
When should method be validated or verified?
Method validation is a demonstration of the method suitability by determining an accuracy of the test results as well as an uncertainty and a traceability of measurements. Method validation is needed for proving whether new method is fit for purpose or specified samples.
What analytical procedures should be validated?
Typical validation characteristics which should be considered are listed below:
- Accuracy.
- Precision.
- Specificity.
- Detection Limit.
- Quantitation Limit.
- Linearity.
- Range.
- Robustness.
