Glossary
Accuracy
How close a measured value is to the known true value or an accepted reference value.
Details
Accuracy is how close a measured value is to the true (or accepted reference) value, while precision is how closely repeated measurements of the same sample agree with each other — if the mean is displaced from the true value, results can be tightly grouped (precise) and still not accurate. ICH Q2(R2) §3.3.1 asks that accuracy be established across the whole reportable range by comparison with a reference material, by spiking recovery, or by comparison with an orthogonal procedure, that it be demonstrated under normal test conditions including the real sample matrix and sample preparation, and that results from an adequate number of concentrations and replicates (for example three concentrations by three replicates) be reported as mean recovery (%) or as the difference from the true value with confidence intervals. Inspections cite recovery experiments run only on standard solutions without the matrix, acceptance criteria set after the results were seen, missing records establishing the accuracy and reproducibility of a test method as required by 21 CFR 211.165(e), and calibration programmes under 211.160(b)(4) that omit limits for accuracy and precision.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
FDA · FDA Warning Letter · 2022-06-14 -
And your firm failed to establish the accuracy, sensitivity…
FDA · FDA Warning Letter · 2022-07-19 -
The analytical test methods had not been validated for accuracy, specificity, and reproducibility.
FDA · FDA Warning Letter · 2022-05-03
