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Validation of Analytical Procedures: Part 2

Validation Parameters

Specificity

Specific evaluation of a test component or reference sample while in the presence of other components.

Accuracy

Closeness or exactness between an accepted true value and an accepted reference value.

Linearity

Ability to obtain test results directly proportional to concentration/amount of analyte.

Range

Interval between the UPPER and LOWER concentration/amount of analyte.

Limit of Detection

Lowest concentration/amount in a test component that CAN BE DETECTED but NOT QUANTIFIED.

Limit of Quantitation

Lowest concentration/amount in a test component that CAN BE QUANTIFIED.

Precision: Repeatability

Precision under the same operating conditions over a short interval of time.

Precision: Intermediate Precision

Precision within-laboratories with variations as per the following: different days/analysts/equipment, etc.

Robustness

Measure of its capacity to remain unaffected by small, but deliberate variations in method parameters.

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.