Report: Compendial Method Verification Report (USP <1226>)

This is a ready-to-use verification report to pair with the verification protocol. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal review and approval. A worked filled specimen follows the template. This is general guidance to adapt, not regulatory advice; confirm the current USP-NF edition and the cited regulation before you rely on them.

Document control header

Field	Entry
Title	Verification Report: `<<FILL: attribute / method>>`
Document number	`<<FILL: report ID>>`
Linked protocol	`<<FILL: protocol ID and version>>`
Article	`<<FILL>>`
Compendial reference and edition	`<<FILL: monograph/general chapter, current USP-NF edition>>`
Author	`<<FILL>>`
Date	`<<FILL>>`

1. Summary of activity

Field	Entry
What was verified	`<<FILL: the compendial procedure for the named attribute and article>>`
Characteristics verified	`<<FILL: e.g. specificity, accuracy, repeatability, intermediate precision>>`
Instruments / CDS / column lot used	`<<FILL>>`
Analysts	`<<FILL>>`
Execution dates	`<<FILL>>`

2. Results against acceptance criteria

Characteristic	Result	Acceptance criterion	Verdict
Specificity (blank/placebo at analyte RT)	`<<FILL>>`	`<<FILL>>`	`<<FILL: Pass/Fail>>`
Peak purity (if PDA)	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Accuracy (per level)	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Repeatability (%RSD)	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Intermediate precision (%RSD)	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
Analyst mean difference	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
LOQ/LOD (if tested)	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
System suitability (each run)	`<<FILL>>`	Per monograph SST	`<<FILL>>`

3. Deviations

Deviation ref	Description	Disposition
`<<FILL: number or "None">>`	`<<FILL>>`	`<<FILL>>`

If a characteristic failed, record the investigation outcome: assignable execution error (corrected, justified, repeated) or a genuine signal that the procedure is not suitable for the article under these conditions (partial revalidation or alternative procedure required).

4. Conclusion

Field	Entry
Conclusion	`<<FILL: The compendial procedure is verified as suitable for routine use with the named article on the named instruments and CDS, by the named analysts, under the stated conditions / Not verified>>`
Released for GMP use	Yes / No (date)
Conditions and re-verification triggers	`<<FILL: new instrument platform, new column chemistry, reformulation, new analyst population>>`

5. Traceability

The executed protocol, raw data (including chromatograms), and this report are linked and retrievable: <<FILL: where stored / record IDs>>. The conclusion traces back to raw data without gaps.

6. References

USP General Chapter <1226> (current USP-NF edition); 21 CFR 211.194(a)(2) and 211.165(e); USP <621> where chromatographic adjustments apply. Confirm current versions before issue.

7. Approvals

Role	Name	Signature	Date
Author (QC SME)	`<<FILL>>`
Reviewer (method validation group)	`<<FILL>>`
Approver (QA, independent of execution)	`<<FILL>>`

Filled specimen

Results for the example finished-product assay by HPLC described in the paired protocol (illustrative).

Characteristic	Result	Criterion	Verdict
Specificity, blank/placebo at API RT	No peak > 0.1% area	No interference > 0.1%	Pass
Peak purity (API)	Passes purity threshold	Passes	Pass
Accuracy, 80% level (mean of 3)	99.4%	98.0 to 102.0%	Pass
Accuracy, 100% level (mean of 3)	100.2%	98.0 to 102.0%	Pass
Accuracy, 120% level (mean of 3)	100.7%	98.0 to 102.0%	Pass
Repeatability, %RSD (n=6)	0.8%	<= 2.0%	Pass
Intermediate precision, %RSD (n=12)	1.3%	<= 3.0%	Pass
Analyst mean difference	0.6% absolute	<= 2.0%	Pass
System suitability (each run)	Resolution, tailing, replicate %RSD within monograph SST	Per monograph	Pass

Conclusion (specimen). The compendial assay procedure is verified as suitable for routine use with this drug product on the named instruments and CDS, by the named analysts, under the stated conditions. The method is released for GMP use. A later change outside the verified conditions (new instrument platform, new column chemistry, reformulation) triggers re-evaluation of the need to re-verify.

Common findings this report prevents

A verification with no clear statement of the conditions the method is verified for.
“System suitability passed, so the method is verified” (SST is day-of-test system fitness, not verification of the method for your article).
A failed characteristic handled as a quiet rerun with no deviation.
A conclusion that cannot be traced back to raw chromatograms.
No re-verification trigger captured for later changes.

How to adapt this report

Number it and link the executed protocol.
Fill the results table from the executed data, not from expectation.
State the verified conditions explicitly in the conclusion.
Capture re-verification triggers so a later change forces a re-look.
Confirm the USP edition and CFR cites are current before issue.