Part 3. VALIDATION
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Validation shall demonstrate that the analytical method complies with the criteria applicable for the relevant performance characteristics.
Different control purposes require different categories of methods. The following table determines which performance characteristic shall be verified for which type of method.
Table 9
Classification of analytical methods by the performance characteristics that have to be determined
| Detection limit CCß | Decision limit CCα | Trueness/recovery | Precision | Selectivity/specificity | Applicability/ruggedness/stability | ||
|---|---|---|---|---|---|---|---|
| S = screening methods; C = confirmatory methods; + = determination is mandatory. | |||||||
| Qualitative methods | S | + | – | – | – | + | + |
| C | + | + | – | – | + | + | |
| Quantitative methods | S | + | – | – | + | + | + |
| C | + | + | + | + | + | + | |
- 3.1.VALIDATION PROCEDURES
- 3.2.GRAPHICAL REPRESENTATION OF THE DIFFERENT ANALYTICAL LIMITS
- 3.3.CALCULATION EXAMPLE FOR RUGGEDNESS TESTING OF MINOR CHANGES ACCORDING TO THE YOUDEN APPROACH (16)
- 3.4.CALCULATION EXAMPLES FOR THE IN-HOUSE VALIDATION PROCEDURE
- 3.5.EXAMPLES FOR THE STANDARD ADDITION METHOD