Approved validation protocol • VAL-P-021 Rev 02
Quantitative HPLC assay of Active X in immediate-release tablets
Intended purpose: reportable finished-product assay across the protocol-defined range. Training acceptance criteria below are fictional and belong only to this validation protocol.
SpecificityPlacebo interference ≤ 0.2%
Repeatability%RSD ≤ 1.5%
Accuracy98.0–102.0%
Response modelProtocol-defined fit
Reportable range80–120%
System suitabilityProcedure-specific
These numbers are training criteria, not universal validation limits. Actual validation characteristics, study designs, replicates and acceptance criteria must follow the method's intended purpose, protocol, applicable guidance and scientific justification.
Validation Preparation Bench
HPLC SYSTEM VLD-03
FLOW 1.000 mL/min
OVEN 35.0°C
λ 254 nm
READY
OVEN 35.0°C
λ 254 nm
READY
80%
100%
120%
A validation study should challenge the intended procedure deliberately. Routine sample testing and validation experiments are not the same activity.
Sequence Builder
The protocol defines a study sequence that separates specificity, precision and accuracy experiments. Do not insert ad-hoc injections that make interpretation ambiguous.
01Blank
02Placebo
03Std 100%
04–09Precision n=6
10–12Accuracy 80%
13–15Accuracy 100%
16–18Accuracy 120%
19–23Response levels
Study Results
| Experiment | Observation | Protocol criterion | Status |
|---|---|---|---|
| Specificity | Not run | Placebo interference ≤ 0.2% | Open |
| Repeatability | Not run | %RSD ≤ 1.5% | Open |
| Accuracy | Not run | 98.0–102.0% | Open |
| Response / range | Not run | Protocol-defined model | Open |
Statistical Review
Precision mean—
Precision %RSD—
Accuracy mean—
Response fit—
A high correlation coefficient by itself does not prove that a model is appropriate. Review residual behavior, range, intended purpose and protocol-defined model checks.
Deviation / Study Event Log
| Event | Impact question | Disposition |
|---|---|---|
| No study events yet | — | Open study |