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    Validating chromatographic methods

    It contains many details concerning the system suitability test.Analytical method validation is performed by regulated laboratory, and deals with the testing of significant method characteristics to ensure that under routine use, the analytical method is accurate, precise, specific, reproducible, and rugged over the whole specified range, for which an analyte (s) is determined.Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success.

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    This FDA Reviewer Guidance is specifically directed at those FDA officials who check the dossiers for a marketing authorisation and gives instructions on which requirements should be made to the validation of analytical chromatographic methods.

    It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations.

    The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications.

    Compendial methods are considered to be valid, but their suitability should be verified under actual conditions of use.

    For non‐compendial procedures, the performance parameters determine specificity/selectivity, linearity, accuracy, precision (repeatability and intermediate precision), detection limit (DL) , quantitation limit (QL) , range, ruggedness, and robustness.

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