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Cleaning Validation Glossary

Intermediate Precision

Test variation in diverse conditions

Intermediate Precision is defined in ICH Q2(R2) Validation of Analytical Procedures as, "Intermediate precision expresses within-laboratories variations. Factors to be considered should include potential sources of variability, for example, different days, different environmental conditions, different analysts and different equipment." Intermediate precision measures the closeness of a measured valued during a single study while exposed to laboratory variations such as a different analyst, different day or an different piece of equipment. For analytical method validation intermediate precision must be assessed with either 6 determinations at 100% of the specification or 3 replicates at 3 different concentrations for a total of 9 determinations.

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