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 verified model of requirements for the validation of analytical procedures, and some guidance in the practical aspects of conducting validation studies in ph...

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Bibliographic Details
Published in:Journal of AOAC International 2001-07, Vol.84 (4), p.1265-1276
Main Authors: Ferenczi-Fodor, K, Végh, Z, Nagy-Turák, A, Renger, B, Zeller, M
Format: Article
Language:English
Subjects:
Chromatography - standards
Quality Control
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Summary: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.
ISSN:1060-3271
1944-7922
DOI:10.1093/jaoac/84.4.1265