Validation Parameters Applicable to Alternative Microbiological Methods
| Parameter | Qualitative Tests, e.g., Sterility Test | Quantitative Tests, e.g., Microbial Enumeration |
|---|---|---|
| Accuracy | No | Yes |
| Precision | No | Yes |
| Specificity | Yes | Yes |
| Detection Limit | No | Yes |
| Quantitative Limit | Yes | Yes |
| Linearity | No | Yes |
| Operating Range | No | Yes |
| Robustness | Yes | Yes |
| Repeatability | Yes | Yes |
| Ruggedness | Yes | Yes |