Validation and quality assurance of planar chromatographic procedures in pharmaceutical analysis

Within the process of the International Conference on Harmonization (ICH), 2 guidelines were released containing a standardized terminology, a verifie d model of requirements for the validation of analytical procedures, and so me guidance in the practical aspects of conducting validation studies in ph armaceutical analysis. For planar chromatographic procedures, which may be used at different levels either in qualitative identity testing, assays, se miquantitative limit tests, or quantitative determination of impurities, th is paper tries to transfer these formal requirements into practical approac hes for validation. Basic acceptance criteria for evaluation of validation experiments based on practical experience are proposed. In addition, select ed parameters for robustness testing of given procedures and quality assura nce of quantitative planar chromatographic testing by control charts is des cribed.