Glossary

Method Qualification

Studies carried out to analyze the quality of an analytical method and to check the "readiness" of a method for validation. The parameters tested in these studies may include specificity, matrix effects, linearity, robustness, etc. Results obtained from these studies could be used for establishing/modifying acceptance criteria, system suitability parameters and for optimizing method parameters. Also known as "Method Feasibility Studies," "Pre-Validation Studies," or "Screening Studies."

Related Compliance: