A Guide to Analytical Method Development: Part 2

Qualification Phase

The qualification phase assists in establishing early preliminary acceptance criteria.

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

Learn more about the Qualification phase of Analytical Development in the infographic below:

You may be interested in the following article:

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