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.