This is a ready-to-use log for recording chain-of-identity and chain-of-custody verification at every handoff in a cell or gene therapy journey. Replace every <<FILL: ...>> placeholder. A field-definition table, the blank log, instructions, and a filled specimen follow. This is general guidance to adapt, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Form number | <<FILL: e.g. FORM-MFG-040-01>> |
| Linked SOP | <<FILL: chain-of-identity/custody SOP-ID>> |
| COI identifier | <<FILL: e.g. COI-XXXXXX>> |
| Product / protocol | <<FILL>> |
| Batch / lot | <<FILL>> |
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Step | Defined handoff name | Yes | Receiving party | At each handoff |
| Site / location | Text | Yes | Receiving party | At handoff |
| COI identifier | Controlled identifier | Yes | Receiving party | At handoff |
| Second identifier | DOB or controlled site ID | Yes | Receiving party | At handoff |
| Identity check result | Pass / Fail | Yes | Verifier | At handoff |
| Custodian in / out | Name or org | Yes | Both parties | At transfer |
| Condition in band? | Yes / No (from logger) | Yes | Receiving party | At receipt |
| Verified by | Name + badge/ID | Yes | Verifier | At handoff |
| Date/time (UTC) | YYYY-MM-DD HH:MM | Yes | Verifier | At handoff |
Blank log
| Step | Site | COI ID | 2nd identifier | Identity result | Custody in/out | Condition in band? | Verified by | Date/time (UTC) |
|---|---|---|---|---|---|---|---|---|
| Apheresis collection | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | NA | <<FILL>> | <<FILL>> |
| Receipt at mfg site | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | Yes / No | <<FILL>> | <<FILL>> |
| Start processing | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | NA | <<FILL>> | <<FILL>> |
| Cryopreservation | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | Yes / No | <<FILL>> | <<FILL>> |
| Final release ship | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | Yes / No | <<FILL>> | <<FILL>> |
| Receipt at center | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | Yes / No | <<FILL>> | <<FILL>> |
| Thaw | <<FILL>> | <<FILL>> | <<FILL>> | Pass / Fail | <<FILL>> | Yes / No | <<FILL>> | <<FILL>> |
| Administration | <<FILL>> | <<FILL>> | <<FILL>> + name confirmed bedside | Pass / Fail | <<FILL>> | NA | <<FILL>> | <<FILL>> |
Instructions
- One log per COI identifier (per patient product). The COI identifier on this log must match the batch record.
- Complete a row at every handoff. A receiving party never accepts custody until both the identity check and the condition check pass.
- Any Fail on the identity check, or any “No” on condition in band, stops the flow: quarantine the product and raise a deviation per the linked SOP. Do not advance.
- Two independent identifiers are mandatory at each step. The COI number alone is not a two-identifier check.
- Retain this log with the batch record for the regional traceability period (EU ATMP: 30 years after product expiry; US per 21 CFR 1271 and cGMP).
Acceptance criteria
- Every row is complete with two identifiers and a named verifier.
- No identity Fail and no condition “No” is left open; each has a deviation reference and disposition.
- The COI identifier is identical across every row and matches the batch and final-product label.
Filled specimen
The following shows a completed log for an example product. Details are illustrative; replace with your own.
| Step | Site | COI ID | 2nd identifier | Identity result | Custody in/out | Condition in band? | Verified by | Date/time (UTC) |
|---|---|---|---|---|---|---|---|---|
| Apheresis collection | Treatment center A | COI-7F3A21 | DOB 1979-04-12 | Pass | Site A to Courier X | NA | RN badge 4471 | 2026-03-02 09:14 |
| Receipt at mfg site | Manufacturing | COI-7F3A21 | DOB 1979-04-12 | Pass | Courier X to Mfg | Yes | Op badge M118 | 2026-03-03 07:50 |
| Cryopreservation | Manufacturing | COI-7F3A21 | Batch BR-7F3A21 | Pass | Mfg internal | Yes | Op badge M204 | 2026-03-10 16:05 |
| Final release ship | Manufacturing | COI-7F3A21 | Lot 7F3A21-FP | Pass | Mfg to Courier Y | Yes | QA badge Q07 | 2026-03-12 11:20 |
| Receipt at center | Treatment center A | COI-7F3A21 | DOB 1979-04-12 | Pass | Courier Y to Site A | Yes | Pharm badge 9912 | 2026-03-13 06:40 |
| Administration | Treatment center A | COI-7F3A21 | DOB 1979-04-12 + name confirmed bedside | Pass | Site A | NA | MD badge 3320 | 2026-03-13 13:35 |
Every row carries the same COI identifier, two identifiers were checked by a named person at each handoff, and the condition stayed in band, so the end-to-end reconciliation ties out: one patient in, one product out.
Common inspection findings this log prevents
- A handoff recorded with one identifier only.
- A custody leg with no identified custodian.
- An out-of-band condition reading accepted without a deviation.
- A COI identifier that does not match the batch record or the final label.
How to adapt this form
- Set the form number and link it to your COI/COC SOP.
- Match the step rows to your actual process map (add or remove handoffs).
- Define your two acceptable secondary identifiers.
- Confirm the regional retention period before use.