Validating a method

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The CHROMacademy Essential Guide to Chromatographic Method Validation June 2011 Dr.The material in the tutorial reflects two excellent previous Validation Viewpoint articles from Mike and Ira Krull which can be found at the links below: In any regulated environment, analytical method validation (AMV) is a critical part of the overall process of validation.If you are using a browser with Java Script disabled please enable it now.

In 1987, the FDA designated the specifications in the current edition of the United States Pharmacopeia (USP) as those legally recognized when determining compliance with the Federal Food, Drug, and Cosmetic Act (3,4).During the IQ phase, all of the activities associated with properly installing the instrument (new, pre-owned, or existing) at the users' site are documented.After the IQ phase is completed, testing is done to verify that the instrument and instrument modules operate as intended in an OQ phase.For HPLC, the PQ test should use a method with a well-characterized analyte mixture, column, and mobile phase.PQ testing should be repeated at regular intervals; the frequency depends upon such things as the ruggedness of the instrument, and the criticality and frequency of use.

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