Module 3 Presentations

07/05/2024

Phases of Validation and Method Utilization

The Organisation for Professionals in Regulatory Affairs

9

Consider the following validation experiments • Specificity • Precision • Repeatability • Intermediate precision • Solution stability • Drug Substance/product Assay

May be considered part of robustness testing but needs consideration earlier than the rest of the robustness test

• •

Linearity

Accuracy, range

Robustness: May be considered part of method development

The Organisation for Professionals in Regulatory Affairs

10

5