Author(s): FerencziFodor K, Vgh Z, NagyTurk A, Renger B, Zeller M, FerencziFodor K, Vgh Z, NagyTurk A, Renger B, Zeller M
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Abstract Within the process of the International Conference on Harmonization (ICH), 2 guidelines were released containing a standardized terminology, a verified model of requirements for the validation of analytical procedures, and some guidance in the practical aspects of conducting validation studies in pharmaceutical analysis. For planar chromatographic procedures, which may be used at different levels either in qualitative identity testing, assays, semiquantitative limit tests, or quantitative determination of impurities, this paper tries to transfer these formal requirements into practical approaches for validation. Basic acceptance criteria for evaluation of validation experiments based on practical experience are proposed. In addition, selected parameters for robustness testing of given procedures and quality assurance of quantitative planar chromatographic testing by control charts is described.
This article was published in J AOAC Int
and referenced in Research & Reviews: Journal of Microbiology and Biotechnology