Out-of-specification(OOS) , FDA Guidance - Lab
https://keytocompliance.com/compliance-best-practices/pharma-best-practices/out-of-specificationoos-fda-guidance-lab-investigation-steps/
Nov 30, 2020 · What is OOS ? An explicit set of requirements is called specification and typically it needs to be satisfied by a material, product, or service. So when a material, product or service fail to meet one or more of the applicable specifications, it is referred to as being out of specification, abbreviated as OOS. FDA Guidance on OOS FDA Requires that
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