This is a ready-to-use cleaning validation summary report. It is the document that states the conclusion an inspector reads first: is the cleaning process validated. Replace every <<FILL: ...>> placeholder with your own specifics, present actual values rather than the word “pass,” and route it through document control. A worked filled specimen follows the template so you can see how a completed version reads. Verify each cited regulation against the current source before you rely on it. This is general guidance to adapt, not legal or regulatory advice.
Approval page
| Field | Entry |
|---|---|
| Report title | Cleaning Validation Summary Report for <<FILL: equipment train / product>> |
| Report number | <<FILL: RPT-ID, e.g. CVR-MFG-022>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Executed under protocol | <<FILL: protocol number and version>> |
| Site / area | <<FILL: site, building, room, equipment train>> |
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Validation) | <<FILL>> | ||
| Toxicology reviewer | <<FILL>> | ||
| Reviewer (QC) | <<FILL>> | ||
| Approver (QA) | <<FILL>> |
1. Purpose and reference to protocol
This report presents the results of the cleaning validation executed under protocol <<FILL: protocol number>> for <<FILL: worst-case product>> on <<FILL: equipment train>>, and states whether the cleaning process is validated. Execution followed the approved protocol except where documented in section 6.
2. Runs executed
| Run | Date | Equipment | Operator(s) | Worst-case product / batch cleaned | Cleaning agent (lot) |
|---|---|---|---|---|---|
<<FILL: 1>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: 2>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: 3>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Confirm the three (or a justified alternative number of) runs were consecutive and successful, with no failure in between. If a run failed and the count restarted, state that history here rather than only showing the passing sequence.
3. Results against acceptance criteria, by location
Present the actual recovery-corrected result and the limit side by side, not a bare pass or fail.
| Location no. | Description | Type | Acceptance limit | Run 1 result | Run 2 result | Run 3 result | Verdict |
|---|---|---|---|---|---|---|---|
<<FILL: 1>> | <<FILL>> | Swab | <<FILL: µg/swab>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: 2>> | <<FILL>> | Swab | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: R1>> | <<FILL>> | Rinse | <<FILL: µg/mL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Additional criterion | Requirement | Run 1 | Run 2 | Run 3 | Verdict |
|---|---|---|---|---|---|
| Visual | No visible residue | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Cleaning agent | Below toxicological limit / conductivity at baseline | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Bioburden | <<FILL: limit>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Endotoxin (if injectable) | <<FILL: limit>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
4. Recovery reconciliation
Confirm the recovery factors applied to these results match the referenced recovery study, on the correct surface material, and that the correction convention matches the one stated in the protocol.
| Residue | Surface | Method | Recovery factor applied | Recovery study reference | Consistent with protocol convention |
|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | Swab | <<FILL>> | <<FILL>> | Yes / No |
<<FILL>> | <<FILL>> | Rinse | <<FILL>> | <<FILL>> | Yes / No |
5. Hold times actually challenged
| Item | Validated maximum (protocol) | Actual hold time challenged | Result at maximum hold |
|---|---|---|---|
| Dirty hold time (DHT) | <<FILL>> | <<FILL>> | <<FILL: within limits>> |
| Clean hold time (CHT) | <<FILL>> | <<FILL>> | <<FILL: within limits>> |
If the actual hold time challenged was shorter than the protocol’s stated maximum, state that explicitly. A validated DHT/CHT is only as long as what was actually demonstrated, not what the protocol hoped to demonstrate.
6. Departures from the protocol
| Departure | Description | Justification | Impact on conclusion |
|---|---|---|---|
<<FILL: none, or list>> | <<FILL>> | <<FILL>> | <<FILL>> |
7. Deviations
Every deviation that occurred during execution is listed with its investigation outcome and impact on the conclusion. Omitting a deviation that occurred is a serious integrity finding, not a shortcut.
| Reference | Description | Root cause | Impact on results | Impact on conclusion |
|---|---|---|---|---|
<<FILL: DEV number or "none">> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
8. Discussion of results near or outside limits
<<FILL: any result near a limit, with the scientific rationale, or "all results comfortably within limits with margin recorded in section 3">>.
9. Conclusion
<<FILL: The cleaning process for [PRODUCT/TRAIN] IS / IS NOT validated.>> All acceptance criteria in the protocol were <<FILL: met / partially met with justification>>. <<FILL: conditions or follow-ups, e.g. items carried into routine verification>>.
10. Routine verification bridge
State the parameters routine, day-to-day cleaning verification will confirm going forward, so the validated state is checked continuously rather than asserted once.
| Monitored parameter | Routine check | Frequency | Escalation if out of range |
|---|---|---|---|
<<FILL: visual, conductivity, cycle time/temp>> | <<FILL>> | <<FILL: each clean / periodic analytical>> | <<FILL: deviation, hold equipment>> |
Reduced or periodic analytical residue testing carried forward after validation (if used): <<FILL: describe, or "none, visual and process-parameter verification only">>.
11. References
21 CFR 211.67 (equipment cleaning and maintenance). EU GMP Annex 15 (Qualification and Validation), 2015 revision. EMA Guideline on setting health-based exposure limits, EMA/CHMP/CVMP/SWP/169430/2012. FDA Guide to Inspections, Validation of Cleaning Processes (1993). PIC/S PI 006-3 (25 September 2007), Recommendations on Validation Master Plan and cleaning validation. PIC/S has published a consolidated successor, PI 006-4, Recommendations on Qualification and Validation, entering into force 1 October 2026; build against PI 006-3 until that date and track the transition.
Confirm the current version of each reference before issue.
12. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
Filled specimen (excerpt)
The following shows the results and conclusion sections completed for a mixing-vessel-train example (worst-case product “Compound X,” recovery-corrected acceptance 43.4 µg/swab, 6 swab locations plus 1 whole-vessel rinse). Numbers are illustrative; replace them with your own.
| Location | Description | Type | Acceptance limit | Run 1 | Run 2 | Run 3 | Verdict |
|---|---|---|---|---|---|---|---|
| 1 | Agitator shaft lower weld | Swab | 43.4 µg/swab | 12.1 | 9.8 | 14.0 | Pass |
| 2 | Spray-ball shadow behind baffle | Swab | 43.4 µg/swab | 18.4 | 15.2 | 16.9 | Pass |
| 3 | Lower gasket groove at outlet | Swab | 43.4 µg/swab | 8.6 | 7.1 | 9.9 | Pass |
| R1 | Whole-vessel final rinse | Rinse | 5.0 µg/mL | 1.2 | 0.9 | 1.4 | Pass |
Deviation excerpt: DEV-2026-0233 (run 2): the field blank for run 2 read marginally above the method’s control limit for background carbon. Investigated to a single contaminated blank vial from a new lot; the swab and rinse results for run 2 were re-verified against a fresh blank from a different lot and confirmed unaffected. Impact on conclusion: none.
Conclusion: the cleaning process for the mixing-vessel train is validated. All 18 swab results and all 3 rinse results across the three runs were below the recovery-corrected acceptance limit with comfortable margin, visual inspection passed all three runs, cleaning agent and bioburden were within limits, and the dirty hold time (7 days) and clean hold time (14 days) were both challenged at their validated maximum and met. Routine verification carries forward visual inspection, rinse conductivity, and a quarterly TOC check on the rinse.
Common inspection observations this report prevents
- The report states “all results passed” with no actual values shown against the limit.
- A deviation that occurred during execution, such as a blank exceedance or a re-sample, is missing from the report.
- Recovery factors used in the disposition do not match the referenced recovery study or its stated surface material.
- The conclusion claims a validated dirty or clean hold time longer than what was actually challenged in the runs.
- No routine verification bridge, so the validated state is asserted once and never checked again.
- Results from a failed, restarted run sequence presented without disclosing the restart.
How to adapt this report
- Reference the exact protocol number and version the runs were executed under.
- Fill the run table and the location-by-location results table with actual recovery-corrected values, not verdict words alone.
- Reconcile every recovery factor used back to its source study and surface material.
- State the actual hold times challenged, not the protocol’s aspirational maximum, if they differ.
- List every deviation with its impact; never omit one.
- State the conclusion plainly and make the routine-verification bridge concrete: parameters, frequency, and escalation.
- Confirm every regulation in section 11 against the current published version before issue.