Method Validation
TestingAlso known as: Analytical Method Validation, Test Method Validation, Method Verification
Demonstrating that a testing method produces reliable results for its intended purpose.
What It Means
Method validation is the process of confirming that an analytical test method is suitable for its intended use by evaluating parameters such as accuracy, precision, specificity, linearity, range, limit of detection (LOD), limit of quantification (LOQ), and robustness. For supplement testing, 21 CFR 111.75(a) requires that the method used for each test be appropriate for its intended purpose and meet 'scientifically valid' criteria. Compendial methods (USP, AOAC Official Methods) are generally considered pre-validated for their stated scope. Non-compendial or in-house methods require the lab to generate validation data. A lab that discloses its method references on COAs (e.g., 'USP <561> Articles of Botanical Origin' or 'In-house method VAL-2024-017') provides transparency about whether the methods are compendial or validated in-house.
What It Is Not
Method validation is not the same as method verification. Verification confirms a lab can perform an already-validated method to the published specifications. Validation generates new evidence that a method works for a particular purpose. A lab using a USP compendial method performs verification; a lab developing a proprietary HPLC method for a novel botanical performs validation. The distinction matters because validation requires substantially more work.
Evidence and References
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