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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

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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
    Thanks
     
    Handy Elfeky, May 20, 2024
    #1