We have developed a method for quantifying urea in wastewater 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 follows the guideline. If the recovery was for example 85% would this be acceptable? Am I wrong concerning my understanding of the validation criteria? Any useful information will be helpful for me as this is the first time for me to deal with validation Thanks
Validation criteria refer to a specific standard, requirement, or rule that must be met in order for an electronic submission to be validated. They are essential to ensure that processes, equipment, and documentation meet regulatory requirements, thus supporting an easy and speedy validation of your submission.
https://www.extedo.com/blog/validation-criteria-in-regulatory-processes
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included.
Validation as per ISO 17025-Method validation includes determining any cross reactivity with other known entities. The lack of cross reactivity demonstrates the specificity of the method. If samples are identical to those for which the method is intended, no verification of specificity is required.
ISO 17468 is a closely linked International Standard, which establishes technical rules for the development or revision and validation of standardized reference methods
http://committee.iso.org/sites/tc34sc9/home/essential-information/content-left-area/validation-of-methods/validation-requirements-on-estab.html
https://www.researchgate.net/publication/6510109_Comparison_of_various_international_guidelines_for_analytical_method_validation
Thanks so much for illustration. I will be grateful if you can advise me which guidelines I can use to validate the developed method for quantifying urea in wastewater