Analytical method validation - Glossary

Analytical method validation is a formal regulatory requirement defined by authorities such as FDA and ICH. It documents whether a laboratory test method is reliable and fit for its intended purpose, such as confirming identity, measuring purity, or detecting harmful contaminants.

Method validation tests the procedure itself on known samples

Validation evaluates the method itself, not only the sample being tested. Laboratories run it repeatedly on samples with known composition to confirm correct, reproducible results before real test materials are analyzed.

Assessed performance characteristics include specificity, meaning the method can distinguish the target from similar molecules; accuracy and precision, meaning results are close to the true value and repeatable; linearity, meaning instrument response is proportional across a range; and detection limits, meaning the smallest amount it can reliably measure.

Without validation, a stated "99% purity" on a lab report may be unverified because the method has not been shown to separate the target from structurally similar impurities accurately. That makes purity claims practically uncertain, and regulators require validated methods for product release and stability testing.

Common confusions around method validation

Validation versus verification: Validation proves that a new or modified method works; verification confirms that an established pharmacopeial method works under specific laboratory conditions.
Analytical versus bioanalytical method validation: Analytical method validation measures the chemical purity of the drug itself; bioanalytical method validation measures drugs in biological matrices such as blood.
One-time proof versus routine QC testing: Validation is the one-time demonstration that the testing tool works; routine QC testing is the daily use of that validated method.

Method validation tests the procedure itself on known samples

Common confusions around method validation

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