This is a ready-to-use between-batch cleaning verification checklist. It is the routine, day-to-day confirmation that a validated cleaning procedure was actually followed and met its established parameters before equipment is released for the next product, distinct from the formal cleaning validation runs themselves and from a general equipment use logbook. Replace every <<FILL: ...>> placeholder with your own specifics and control it under your normal document control. A filled specimen follows. Verify each cited regulation against the current source before you rely on it.
How this differs from other cleaning records
This checklist is not the cleaning validation protocol or report; those prove the procedure works in the first place. See the cleaning validation protocol and cleaning validation summary report templates for that. It is also not a general equipment use logbook; see the equipment use, cleaning, and status logbook for that broader, multi-purpose record. This checklist is the release gate performed after every cleaning event on validated, shared, multi-product equipment: did this specific clean follow the validated parameters closely enough to trust the equipment for the next product, without running full analytical residue testing on every batch.
Document control header
| Field | Entry |
|---|---|
| Checklist title | Between-Batch Cleaning Verification, <<FILL: EQUIPMENT / TRAIN>> |
| Document / form number | <<FILL: CHK-ID, e.g. CVV-MFG-022>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: date>> |
| Governing cleaning validation protocol/SOP | <<FILL: protocol/SOP number>> |
| Equipment name / ID | <<FILL>> |
Instructions
Complete this checklist immediately after the cleaning cycle and before the equipment is released for the next product or campaign. Every item is pass, fail, or not applicable; a fail holds the equipment and triggers a deviation. Do not release equipment against an incomplete checklist.
Verification items
| # | Item | Reference | Pass / Fail / N/A |
|---|---|---|---|
| 1 | Cleaning performed per the current, effective version of <<FILL: cleaning SOP-ID>> | Cleaning SOP | <<FILL>> |
| 2 | Cleaning agent, concentration, and lot match the validated procedure | Cleaning SOP; agent COA | <<FILL>> |
| 3 | Cycle time, temperature, and flow/action match the validated parameters (CIP skid printout or manual log) | Validated cleaning parameters | <<FILL>> |
| 4 | Dirty hold time from end of manufacturing to start of cleaning was within the validated maximum | Batch record; cleaning start time | <<FILL>> |
| 5 | Visual inspection performed under the defined lighting, distance, and angle: no visible residue | Cleaning validation protocol visual criteria | <<FILL>> |
| 6 | Rinse conductivity (or pH) at or below the established baseline, confirming cleaning-agent rinse-off | Validated baseline value | <<FILL>> |
| 7 | Equipment is dry / prepared per the defined post-clean condition before storage | Cleaning SOP | <<FILL>> |
| 8 | Equipment status label updated to “Clean” with date, time, and identity | Status labeling procedure | <<FILL>> |
| 9 | Clean hold time clock started and within the validated maximum at time of next use | Validated CHT | <<FILL>> |
| 10 | Second-person verification completed for a changeover to a different product | <<FILL: SOP-ID for line clearance>> | <<FILL>> |
| 11 | Any deviation from the above raised and referenced | <<FILL: deviation SOP-ID>> | <<FILL>> |
Release decision
| Field | Entry |
|---|---|
| All applicable items pass | Yes / No |
| If No, equipment status | Quarantined / Hold, deviation number <<FILL>> |
| Released for | <<FILL: next product / campaign>> |
| Verifier (name, signature, date) | <<FILL>> |
| Second-person / QA reviewer (name, signature, date, required for changeover) | <<FILL>> |
References
21 CFR 211.67 (equipment cleaning and maintenance), 211.182 (equipment cleaning and use log). EU GMP Annex 15 (Qualification and Validation), 2015 revision. FDA Guide to Inspections, Validation of Cleaning Processes (1993): visual inspection necessary but not sufficient on its own.
Confirm the current version and clause numbers of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
Filled specimen
The following shows the checklist completed for an example changeover on a shared mixing vessel train. The numbers are illustrative; replace them with your own.
| # | Item | Pass / Fail / N/A |
|---|---|---|
| 1 | Cleaning per SOP-MFG-014, v3.0 | Pass |
| 2 | 2% w/v alkaline detergent, lot AD-2206-11, matches validated procedure | Pass |
| 3 | CIP cycle 45 min at 65C, printout attached, matches validated parameters | Pass |
| 4 | Dirty hold time 6 hours, within validated maximum of 7 days | Pass |
| 5 | Visual inspection under 500 lux at arm’s length: no visible residue | Pass |
| 6 | Final rinse conductivity 1.8 µS/cm, baseline is <= 2.0 µS/cm | Pass |
| 7 | Vessel drained and ports capped per SOP | Pass |
| 8 | Status label updated: Clean, 12-Jun-2026 14:20, initials JR | Pass |
| 9 | Clean hold time clock started 12-Jun-2026 14:20, validated maximum 14 days | Pass |
| 10 | Second-person line clearance completed for changeover to next product | Pass |
| 11 | No deviations | N/A |
Release decision: all items pass; equipment released for the next product at 14:25 on 12-Jun-2026, verified by J. Romero, second-person reviewed by L. Tan.
In this example every parameter tied directly back to the validated procedure rather than a general “looked clean” judgment, and the second-person check on the changeover is what actually catches a mislabeled or skipped step before the next product starts.
Common inspection observations this checklist prevents
- Equipment released for the next product with no record that cleaning parameters actually matched the validated procedure.
- Visual inspection recorded as “clean” with no stated lighting, distance, or angle behind the judgment.
- Dirty or clean hold time not checked against the validated maximum at the point of use.
- A changeover to a different product with no second-person or QA verification.
- A failed item on the checklist with the equipment used anyway and no deviation raised.
How to adapt this checklist
- Set your document number, governing protocol/SOP, and equipment ID in the header.
- Pull the exact validated parameters (agent, concentration, time, temperature, conductivity baseline, DHT/CHT maximums) from your cleaning validation protocol and report into items 2-3 and 6, 9.
- Add or remove items to match your equipment: an automated CIP skid may auto-log time/temp; a manual COP process needs more operator-recorded fields.
- Point the deviation and line-clearance references to your real procedures.
- Confirm every regulation in the references against the current published version before issue.