An excursion investigation is more than an account of the event; it enables a decision on the product and stops the event from repeating. The 2022 TITCK Good Distribution Practice Guideline requires a written procedure for investigating temperature excursions during transport (Section 10.2) and provides for corrective and preventive action (CAPA) on deviations from procedures (Section 2.2).
| Part | What is written |
|---|---|
| Event | Time noticed, place, device, alarm, first response |
| Measurement | Raw data, sampling interval, device ID, clock difference |
| Impact | Product, batch, quantity, related shipments |
| Assessment | Probable cause, alternative explanations, open questions |
| Follow-up | Owner, action, date to check its effect |
The event row holds more than duration and degrees: was a door open, did the generator start. The root cause usually turns up in that surrounding detail; start with the change just before the event, ask 'why' several times in a row, and do not pin the cause on one person or fault without firm evidence.
The action must be measurable. 'Staff were reminded' is not an action; a changed threshold, a clause added to the instruction, a different container type or an updated checklist is, and its effect is checked after a set period. If the same excursion repeats, the root cause was wrong and the file is reopened.
The product decision belongs to the responsible person, not to the investigation: under the guideline the responsible pharmacist of a pharmaceutical warehouse decides the final status of returned, rejected or recalled product (Section 3.2). The investigation supplies the basis: the affected batches, the total exposure, and how it compares with the product's stability data.