Method validation means full validation as per ICH Q2 guidelines.
Methods for targeted leachables studies need to be validated, i.e. the method is validated for a specific compound in a specified matrix.
Methods for extractables screening studies need to be qualified.
Qualification involves the application of a subset of the parameters listed in the ICH Q2 guidelines to a model compound/standard. The method is then applied to a variety of compounds in a variety of matrixes.
SST is used to verify that the chromatographic system is adequate for the intended analysis.