How close the test results are to the "true" value.
How closely the results of multiple samples match each other (repeatability and intermediate precision). 2. Specificity
The lowest amount of analyte that can be measured with suitable precision and accuracy. 5. Robustness Pda Technical Report 13 Pdf Free Download
Below is a comprehensive article detailing the significance, history, and core contents of , which focuses on the fundamentals of analytical method validation.
Technical Report 13 breaks down validation into specific "analytical performance characteristics." When a lab validates a method, they are essentially testing it against these criteria: 1. Accuracy and Precision How close the test results are to the "true" value
First revised in 2014 (originally published in 1990), TR 13 provides a practical framework for validating analytical procedures. It aligns with global regulatory expectations, such as those from the and ICH (International Council for Harmonisation) , specifically ICH Q2(R1).
Understanding PDA Technical Report 13: Fundamentals of Analytical Method Validation Specificity The lowest amount of analyte that can
This ensures that the method can distinguish the target substance (the analyte) from other components that might be present, such as impurities, degradants, or excipients in the formula. 3. Linearity and Range
One of the most practical sections of TR 13 involves robustness—the measure of a method's capacity to remain unaffected by small, deliberate variations in method parameters (e.g., changes in pH, temperature, or flow rate). Why This Report Matters for Sterile Manufacturing
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