A Guide to Analytical Method Development: Part 2

Qualification Phase

The qualification phase assists in establishing early preliminary acceptance criteria.

Recommended qualification 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 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:

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.