Analytical Method Validation
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The documented process of demonstrating that an analytical procedure is suitable for its intended use, evaluating parameters such as accuracy, precision, specificity, linearity, range, and detection or quantitation limits, and robustness, before the method is used to release, characterize, or support the stability of a GxP product.
Which parameters must be evaluated depends on the method’s purpose: an identification test needs specificity but not a full quantitative package, while a method quantifying an impurity near a reporting threshold needs a validated limit of detection and quantitation as well as demonstrated linearity across the relevant range.
Method validation is what establishes suitability in the first place; it is separate from analytical method transfer, which later confirms that an already-validated method still performs to the same standard when it moves to a different laboratory.
- —Parameters evaluated (accuracy, precision, specificity, linearity, range, LOD/LOQ, robustness) depend on the method’s intended purpose
- —Required before a method is used to release, characterize, or support stability of product
- —Governed primarily by ICH Q2(R2), harmonized with USP <1225>
- —Distinct from analytical method transfer, which verifies equivalence at a receiving laboratory
ICH Q2(R2) Validation of Analytical Procedures; USP <1225> Validation of Compendial Procedures
Frequently asked questions
What is Analytical Method Validation?
The documented process of demonstrating that an analytical procedure is suitable for its intended use, evaluating parameters such as accuracy, precision, specificity, linearity, range, and detection or quantitation limits, and robustness, before the method is used to release, characterize, or support the stability of a GxP product.
Which regulations cover Analytical Method Validation?
ICH Q2(R2) Validation of Analytical Procedures; USP <1225> Validation of Compendial Procedures