Analytical Procedure Validation Report

Reports the outcome against criteria stated in the approved protocol. If a criterion here differs from the protocol, that is a deviation to be documented, not an edit to be made.

1. Summary of outcome

• Validated reportable range: [ ]
• Statement of fitness for the intended purpose, and who is making it: [ ]

2. Response

• Levels and replicates actually run: [ ]
• Calibration model and weighting: [ ]
• Slope, intercept, and their confidence intervals: [ ]
• Coefficient of determination: [ ]
• Analysis of deviation from the regression line (residual plot, lack-of-fit test, back-calculated relative error per level): [ ]

3. Accuracy

• Approach used: [ ] reference material / spiking / orthogonal comparison
• For impurities, basis of determination: [ ] w/w / area %

4. Precision

• Intermediate precision factors varied: [ ] days / analysts / instruments / environment
• Reproducibility, if performed: [ ]

5. Lower range limits

• DL, and the approach used to determine it: [ ]
• QL, and the approach used to determine it: [ ]
• Confirmation of the estimated limit with samples at or near it: [ ]
• For impurity procedures, QL relative to the reporting threshold: [ ]

6. Specificity and stability-indicating properties

• Interference results: [ ]
• Forced degradation results and peak purity / mass balance: [ ]
• Relative response factors, and any correction factor applied: [ ]

7. Robustness

• Solution stability demonstrated over: [ ]

8. Deviations

• Out-of-criteria individual results, and whether they were included in the reported statistics: [ ]

9. Raw data traceability

Every reported number must be traceable to a retained record. A report whose numbers cannot be reproduced from the raw data is the finding that costs the most to remediate.

• Software and version used for calculations: [ ]
• Calculation verification method: [ ]
• Script outputs retained as records: [ ]

10. Conclusion and lifecycle

• Conclusion against the ATP / intended purpose: [ ]
• Conditions or limitations on use: [ ]
• Ongoing performance monitoring planned: [ ]
• Revalidation triggers identified: [ ]

11. Approvals