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.

Field	Value
Report number / version	[ ]
Protocol number / version executed	[ ]
Analytical procedure identifier and version	[ ]
Governing framework	[ ]
Execution dates	[ ]
Analysts and instruments	[ ]
Author / date	[ ]
Technical reviewer / date	[ ]
Quality unit approval / date	[ ]

1. Summary of outcome

Characteristic	Criterion (from protocol)	Result	Interval reported	Met
Specificity / selectivity	[ ]	[ ]	—	[ ]
Response	[ ]	[ ]	[ ]	[ ]
Lower range limit (DL / QL)	[ ]	[ ]	—	[ ]
Accuracy	[ ]	[ ]	[ ]	[ ]
Repeatability	[ ]	[ ]	[ ]	[ ]
Intermediate precision	[ ]	[ ]	[ ]	[ ]

• 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

Level	n	Mean recovery (%)	Bias (%)	Confidence interval	Met
[ ]	[ ]	[ ]	[ ]	[ ]	[ ]

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

4. Precision

Level	Component	SD	%RSD	df	Interval	Met
[ ]	repeatability	[ ]	[ ]	[ ]	[ ]	[ ]
[ ]	between-group	[ ]	[ ]	[ ]	—	—
[ ]	intermediate 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

Parameter	Range varied	Effect on the reportable result	Conclusion
[ ]	[ ]	[ ]	[ ]

• Solution stability demonstrated over: [ ]

8. Deviations

#	Description	Assessment of impact	Disposition	Approved by
[ ]	[ ]	[ ]	[ ]	[ ]

• 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.

Reported item	Raw data location	Instrument / system	Acquisition date	Reviewed by
[ ]	[ ]	[ ]	[ ]	[ ]

• 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

Role	Name	Signature	Date
Author
Technical reviewer
Quality unit