This is a ready-to-use milestone tracking log for the vein-to-vein turnaround of a single-patient cell or gene therapy batch.
It exists so a delay against the planned schedule is caught the day it happens, by whoever owns that milestone, rather than discovered as a surprise at the treatment center.
Replace every <<FILL: ...>> placeholder with your own process milestones and planned durations. A worked filled specimen follows.
Batch identification
| Field | Entry |
|---|---|
| COI identifier / batch number | <<FILL>> |
| Product | <<FILL>> |
| Planned infusion date | <<FILL>> |
Milestone tracking
| Milestone | Planned date | Actual date | Owner | Variance (days) | Escalated? |
|---|---|---|---|---|---|
| Apheresis collection | <<FILL>> | <<FILL>> | Treatment center | <<FILL>> | Yes/No |
| Receipt at manufacturing site | <<FILL>> | <<FILL>> | Manufacturing | <<FILL>> | Yes/No |
| Manufacturing start | <<FILL>> | <<FILL>> | Manufacturing | <<FILL>> | Yes/No |
| Harvest / cryopreservation | <<FILL>> | <<FILL>> | Manufacturing | <<FILL>> | Yes/No |
| Release testing complete (gating panel) | <<FILL>> | <<FILL>> | QC | <<FILL>> | Yes/No |
| QP / quality unit disposition | <<FILL>> | <<FILL>> | QA / QP | <<FILL>> | Yes/No |
| Shipment to treatment center | <<FILL>> | <<FILL>> | Logistics | <<FILL>> | Yes/No |
| Receipt at treatment center | <<FILL>> | <<FILL>> | Treatment center | <<FILL>> | Yes/No |
| Infusion | <<FILL>> | <<FILL>> | Clinical team | <<FILL>> | Yes/No |
Escalation rule
Any milestone that slips more than <<FILL: e.g. 1 day>> against plan is escalated the same working day to <<FILL: e.g. the CGT program manager and QA>>, with the downstream impact on the infusion date assessed immediately, not at the next scheduled meeting.
Variance summary
| Question | Answer |
|---|---|
| Total vein-to-vein duration, planned | <<FILL>> |
| Total vein-to-vein duration, actual | <<FILL>> |
| Any milestone escalated? | <<FILL>> |
| Root cause of variance (if any) | <<FILL>> |
| Clinical team notified of any schedule change? | Yes / No / Not applicable |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Log maintained by (Program manager) | <<FILL>> | ||
| Reviewed by (QA) | <<FILL>> |
Filled specimen (excerpt)
| Milestone | Planned date | Actual date | Variance | Escalated? |
|---|---|---|---|---|
| Apheresis collection | 2026-08-01 | 2026-08-01 | 0 | No |
| Receipt at manufacturing site | 2026-08-02 | 2026-08-02 | 0 | No |
| Release testing complete | 2026-08-13 | 2026-08-15 | plus 2 days | Yes |
| QP disposition | 2026-08-14 | 2026-08-16 | plus 2 days | Yes |
| Infusion | 2026-08-17 | 2026-08-19 | plus 2 days | Yes |
Variance summary: a 2-day delay in the rapid sterility readout pushed release testing, QP disposition, and infusion each back by 2 days. Escalated same day to the program manager and QA; treating physician notified of the revised infusion date within the hour.
Common inspection findings this log prevents
- A schedule slip discovered only when the treatment center calls asking where the product is.
- No named owner per milestone, so a delay has no clear accountable party.
- A delay absorbed silently without a documented root cause or clinical notification.
How to adapt this log
- Replace the milestone list with your actual process steps and their planned durations.
- Set your own escalation threshold and escalation recipients.
- Decide whether this log is maintained manually or generated from your MES/scheduling system; either way, the escalation rule must be enforced in real time, not reviewed retrospectively.