This is a ready-to-use record to document a single transit (or storage) temperature excursion from detection to disposition. It is the paired record for the excursion management SOP. Replace every <<FILL: ...>> placeholder. A field guide and a filled specimen follow.
Field guide
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Record number | <<FILL: scheme>> | Yes | QA | At open |
| Product / lot / quantity | Text / number | Yes | Logistics | At open |
| Shipment / order reference | Text | Yes | Logistics | At open |
| Logger serial / type | Text | Yes | Logistics | At open |
| Calibration reference and validity | Text / date | Yes | Logger owner | At open |
| Detected by / date | Text / date | Yes | Detector | At open |
Section 1: Event and quarantine
| Field | Entry |
|---|---|
| Record number | <<FILL>> |
| Product / lot / quantity | <<FILL>> |
| Shipment / order reference | <<FILL>> |
| Logger serial / type | <<FILL>> |
| Detected by / date | <<FILL>> |
| Quarantine applied (Y/N, system status) | <<FILL>> |
| Sponsor QA notified (date / time) | <<FILL>> |
| Raw logger data received (Y/N, location) | <<FILL>> |
Section 2: Trustworthiness gate (must pass before assessment)
| Check | Result (Pass/Fail) | Note |
|---|---|---|
| Calibration current and traceable | <<FILL>> | <<FILL>> |
| Logger serial matches dispatch record | <<FILL>> | <<FILL>> |
| Logging interval bounds the excursion duration | <<FILL>> | <<FILL>> |
| No custody gap / data gap (profile brackets custody) | <<FILL>> | <<FILL>> |
| Gate result | <<FILL: PASS / FAIL>> | If FAIL, default to reject/hold and raise a DI deviation |
Section 3: Excursion characterization
| Field | Entry |
|---|---|
| Limit(s) breached | <<FILL>> |
| Peak temperature | <<FILL>> |
| Segments above limit (count, durations) | <<FILL>> |
| Cumulative time outside limit | <<FILL>> |
| MKT (supporting only) | <<FILL>> |
Section 4: Acceptance-rule comparison
| Field | Entry |
|---|---|
| Product stability-derived allowance | <<FILL: peak / cumulative-time / freeze rule>> |
| Cumulative excursion budget already consumed by this lot | <<FILL>> |
| Within allowance? (Y/N) | <<FILL>> |
| If outside: stability / regulatory assessment reference | <<FILL>> |
Section 5: Disposition
| Field | Entry |
|---|---|
| Disposition | <<FILL: Release / Reject / Release-with-restriction>> |
| Rationale (tied to the rule, not to MKT alone) | <<FILL>> |
| Inventory status updated (Y/N) | <<FILL>> |
| Deviation / CAPA raised (number or N/A) | <<FILL>> |
| QA disposition (name, signature, date) | <<FILL>> |
Acceptance criteria
- Section 2 gate passed before any disposition, or the shipment was held / rejected and a DI deviation raised.
- The disposition rationale references the stability-derived rule, not MKT alone.
- Raw logger data, calibration certificate, and this record are retained together.
References
EU GDP (2013/C 343/01), Chapter 9 (Transportation). USP General Chapter <1118> (Monitoring Devices). MHRA GxP Data Integrity Guidance; PIC/S PI 041.
Confirm current versions before issue.
Filled specimen
Illustrative completed record for an example 2-8 C biologic shipment.
| Section | Entry |
|---|---|
| Record number | EXC-2026-0231 |
| Product / lot / quantity | mAb-217, lot L26-118, 50 units |
| Logger serial / type | TL-2291847, single-use electronic |
| Trustworthiness gate | Calibration valid to Dec 2026, NIST-traceable; serial matched dispatch; 10-min interval; profile 06:00-23:32 brackets custody. Gate: PASS |
| Characterization | Above 8 C: 2 segments (20 + 50 min), cumulative 70 min; peak 9.4 C; MKT 5.9 C |
| Acceptance-rule comparison | Allowance: up to 96 h cumulative 8-25 C; 70 min within budget; no prior excursions on lot. Within allowance: Yes |
| Disposition | Release; rationale: within studied allowance, gate passed, budget recorded; QA R. Gomez, 12 Jun 2026 |
The record shows the gate first, the rule second, and MKT used only as support. That ordering is what makes the release defensible to an inspector.
Common inspection findings this record prevents
- A disposition with no record of whether the temperature data could even be trusted.
- A release justified by MKT while a peak or cumulative-time limit was breached.
- Raw logger data not retained with the disposition.
How to adapt this form
- Pre-load the product allowances or reference the stability document that holds them.
- Add a field for the cumulative-budget ledger if you track allowance consumption across a lot’s life.
- Point the deviation / CAPA field to your real procedures.