# 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 | | | |