Log: Vein-to-Vein Turnaround Tracking

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.