This is a ready-to-use pre-release checklist for a single-patient (autologous) cell or gene therapy batch. Replace every <<FILL: ...>> placeholder with your own specifics. Complete every item before the Qualified Person / responsible quality unit certifies release; do not release with any item unresolved.
Batch identification
| Field | Entry |
|---|---|
| Product | <<FILL>> |
| COI identifier / batch number | <<FILL>> |
| Patient identifier (per your pseudonymization policy) | <<FILL>> |
| Manufacturing site | <<FILL>> |
Chain of identity and custody
- COI identifier is consistent across every record from collection to this disposition, with no gaps or transcription errors.
- Every handoff shows two independent identifiers verified by a named person.
- Chain of custody record shows no gap in custodianship and the full temperature trace is within band for the entire journey, or any excursion has a documented, QA-approved disposition.
Infusion-gating release panel
- Identity (cell phenotype) result:
<<FILL>>, within spec: Yes / No - Transduction efficiency / vector copy number result:
<<FILL>>, within spec: Yes / No - Viable cell dose result:
<<FILL>>, meets target dose: Yes / No - Viability result:
<<FILL>>, within spec: Yes / No - Endotoxin result:
<<FILL>>, within spec: Yes / No - Rapid sterility result:
<<FILL>>, no growth at readout: Yes / No - RCR/RCL testing (where required at this stage) complete: Yes / No / Not applicable
If any gating result is out of specification
- Pre-approved OOS-release SOP reference:
<<FILL: SOP-ID>> - Documented risk assessment attached: Yes / No
- Treating physician notified and notification recorded: Yes / No
- Patient informed per the SOP: Yes / No
- Joint QP/quality unit and physician authorization recorded: Yes / No
If any box in this section is No, do not release; quarantine and investigate.
For-the-record tests (pending, do not gate infusion)
| Test | Committed report date | Status |
|---|---|---|
| Full sterility (compendial) | <<FILL>> | Pending / Reported |
| RCR/RCL (post-infusion testing, if applicable) | <<FILL>> | Pending / Reported |
| Potency | <<FILL>> | Pending / Reported |
- A defined process exists to act on any later failure of a for-the-record test (physician notification, investigation, health-authority reporting as applicable).
Final disposition
| Question | Answer |
|---|---|
| All infusion-gating tests within spec, or OOS-release pathway completed? | Yes / No |
| COI/COC reconciliation ties out? | Yes / No |
| Disposition | Release / Hold / Reject |
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| QC release reviewer | <<FILL>> | ||
| Qualified Person (EU) / responsible quality unit (US) | <<FILL>> | ||
| Treating physician (only if OOS-release pathway used) | <<FILL>> |
Filled specimen (excerpt)
| Item | Result | Within spec? |
|---|---|---|
| Identity (cell phenotype) | Conforms | Yes |
| Viable cell dose | Meets target | Yes |
| Viability | Above limit | Yes |
| Endotoxin | Below limit | Yes |
| Rapid sterility | No growth | Yes |
COI/COC: identifier COI-7F3A21 consistent across all 8 handoff records; no gaps; cold-chain trace within band throughout transport.
Disposition: all gating tests within spec, COI/COC ties out, released by QP with for-the-record tests (full sterility, RCR/RCL, potency) tracked to their committed report dates.
Common inspection findings this checklist prevents
- A batch released with an infusion-gating test still pending, not yet reported as within spec.
- An OOS result released without the pre-approved SOP, documented risk assessment, or recorded physician notification.
- For-the-record tests that fail after infusion with no defined follow-up action.
- A COI or COC gap discovered after release rather than caught at the disposition checkpoint.
How to adapt this checklist
- Set your product’s actual gating panel and specs from your approved control strategy.
- Point the OOS-release section to your real, pre-approved SOP; do not leave this section generic at the point of use.
- Confirm your for-the-record test list and committed report dates match your validated release strategy.