The article proposes an integration of method validation, transfer, and verification process ... in the fishbone diagram or table. It must be controlled by system suitability requirements. Table II: ...

The authors describe a method ... validation parameters. Systematic analysis (e.g., fishbone diagram) is done based on historical knowledge. The QbD/DOE output confirms those that are critical.

To be confident in the reliability of this data it is crucial that the methods are fit for purpose. Analytical method validation is the process of demonstrating that a method is suitable for its ...