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Validation criteria

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by Handy Elfeky, May 20, 2024.

  1. Handy Elfeky

    Handy Elfeky New Member

    Mar 12, 2024
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    We have developed method for quantify urea in waste water and the method should be validated. I'm a bit confused concerning the validation criteria. I have searched for that in international guidelines but no data. I mean if I'm going to follow Eurachem or IGH guidelines for accuracy or precision there is no data for how much the recovery or precision %. In some publications I have seen for example recovery % = 99 and they mentioned that this is follow the guideline. If the recovery was for example 85% is this will be acceptable?
    Am I wrong concerning my understanding the validation criteria?
    Any useful information will be helpful for me as this is the first time for me to deal with validation