Report: Analytical Method Transfer

This is a ready-to-use report for closing out an analytical method transfer. It mirrors the protocol section by section and states the result against each predefined criterion as met or not met, never averaged or narrated into a favorable impression. Replace every <<FILL: ...>> placeholder. This content is educational reference, not legal or regulatory advice.

Field	Entry
Report number	`<<FILL>>`
Protocol number and version referenced	`<<FILL>>`
Method	`<<FILL>>`
SU / RU	`<<FILL>>`
Execution dates	`<<FILL>>`

1. Objective (as stated in the protocol)

<<FILL: restate the protocol objective verbatim>>

2. Approach executed

Field	Entry
Transfer approach	`<<FILL>>`
Actual execution vs plan	`<<FILL: confirm as-planned, or describe any deviation>>`

3. Deviations from protocol

#	Deviation	Impact assessment	Disposition
`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL: no impact / repeat required / investigated, see attached>>`

If none, state “No deviations from the approved protocol occurred.”

4. Results against predefined criteria

Parameter	Predefined criterion	Result	Met / Not met
`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`

5. Investigation of any not-met criterion

For each Not Met result: assignable cause investigated, root cause found (or not found), corrective action, and outcome of any repeat under the same protocol.

Criterion not met	Investigation reference	Root cause	Repeat result
`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`

6. Conclusion

Field	Entry
Overall conclusion	`<<FILL: Transferred / Not transferred / Transferred with conditions>>`
Conditions (if any)	`<<FILL>>`
Effective date for RU to begin routine use	`<<FILL: no earlier than the date of the last required signature below>>`

7. Attachments

Raw data from both labs, including all preparations and replicate determinations.
System suitability data for every run.
Chromatograms or instrument outputs.
Statistical calculations with the predefined criteria stated.
Readiness checklist and any deviation records.

8. Approvals

Role	Name	Signature	Date
Report author	`<<FILL>>`
SU Quality Assurance	`<<FILL>>`
RU Quality Assurance	`<<FILL>>`

Filled specimen

Excerpt of a completed report for the example small-molecule assay transfer. Illustrative only.

Parameter	Predefined criterion	Result	Met / Not met
Assay accuracy/equivalence	90% CI within +/-3.0%	SU mean 99.6%, RU mean 100.8%, 90% CI of difference 0.26% to 2.14%	Met
Assay precision (RU)	%RSD <= 2.0%	RU %RSD 0.94%	Met
Related substances	RU within +/-25% relative of SU	Largest relative difference 11%	Met
System suitability	Resolution >= 2.0, tailing <= 2.0	Resolution 2.4, tailing 1.3, both labs, every run	Met

Conclusion: Transferred, no conditions. RU authorized to begin routine release testing effective the date of the last QA signature below, not before.

Common inspection findings this report prevents

A report narrates “results were comparable” without stating each criterion as met or not met individually.
Routine release testing begins before both QA units sign the report.
A not-met criterion is explained away in prose rather than investigated with a documented root cause.
The report cannot be reconstructed by a reviewer who was not present because raw data and calculations are not attached.

How to adapt this report

Set the report number, protocol reference, method, and sites in the header.
Mirror every criterion from the approved protocol’s acceptance table in section 4, in the same order.
For any not-met result, complete section 5 in full before drafting a conclusion; do not average a failure away.
Confirm the effective date in section 6 is not earlier than the last required approval signature.

Header