Analytical Method Validation
Analytical Method Validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency ofanalytical results; it is an integral part of any good analytical practice.
When is Analytical Validation Required?
Analytical methods need to be validated or revalidated:
- before their introduction into routine use
- whenever the conditions change for which the method has been validated (e.g., an instrument with different characteristics or samples with a different matrix); and
- whenever the method is changed and the change is outside the original scope of the method.
USP Guidelines
The USP has published specific guidelines for method validation for compound evaluation that Premier Validation Consultants ahere to when working on Analytical Method validation projects.
These guidelines include:
- Accuracy
- Precision
- Specificity
- Limit of detection
- Limit of quantitation
- Linearity and range
- Ruggedness
- Robustness
