This is a ready-to-use checklist the QP or QA works through before certifying an IMP batch. It turns the certification decision into a set of pass/fail confirmations, each with an evidence reference, so nothing that matters is assumed. A single unresolved item holds certification. Replace <<FILL: ...>> placeholders, and confirm each cited regulation against the current source. A filled specimen follows.
Control header
| Field | Entry |
|---|---|
| Batch / lot number | <<FILL>> |
| IMP name / code | <<FILL>> |
| Trial / protocol number | <<FILL>> |
| PSF reference / version | <<FILL>> |
| Prepared by | <<FILL: QA name / date>> |
| QP | <<FILL: name>> |
How to use
Mark each item Pass, Fail, or N/A with an evidence reference. A Fail holds certification until resolved. N/A requires a one-line justification (for example imported-product items for an EU-manufactured batch).
1. Records and manufacture
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 1.1 | Batch manufacturing record complete and reviewed | <<FILL>> | <<FILL>> |
| 1.2 | Packaging batch record complete and reviewed, with label reconciliation | <<FILL>> | <<FILL>> |
| 1.3 | Manufacturing/importing site holds a current MIA(IMP) and operates under GMP | <<FILL>> | <<FILL>> |
| 1.4 | GMP appropriate to the stage of development applied and documented | <<FILL>> | <<FILL>> |
2. Specification compliance
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 2.1 | Certificate of analysis present; batch meets the PSF specification | <<FILL>> | <<FILL>> |
| 2.2 | Testing complete; any OOS investigated and closed | <<FILL>> | <<FILL>> |
| 2.3 | PSF is current relative to the approved IMPD (no drift) | <<FILL>> | <<FILL>> |
| 2.4 | Released-against spec, PSF, IMPD/IND, and CoA all agree | <<FILL>> | <<FILL>> |
3. Authorisation
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 3.1 | Trial authorised (CTA) in each country of intended use | <<FILL>> | <<FILL>> |
| 3.2 | Authorisation covers the intended arm(s) of the trial | <<FILL>> | <<FILL>> |
| 3.3 | Sponsor order present for the batch | <<FILL>> | <<FILL>> |
4. Labelling and blinding
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 4.1 | Labelling meets CTR Annex VI particulars for each country, including translations | <<FILL>> | <<FILL>> |
| 4.2 | Any expiry extension done under the controlled procedure with second check and blind protection | <<FILL>> | <<FILL>> |
| 4.3 | Blinding integrity confirmed (without the QP needing treatment assignments) | <<FILL>> | <<FILL>> |
5. Imported product (if applicable)
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 5.1 | GMP standard of the third-country site confirmed | <<FILL>> | <<FILL>> |
| 5.2 | Documented GMP-equivalence assessment on file | <<FILL>> | <<FILL>> |
| 5.3 | Importation testing performed, or reduction justified and documented | <<FILL>> | <<FILL>> |
6. Deviations and final
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 6.1 | All deviations affecting the batch assessed and closed or justified | <<FILL>> | <<FILL>> |
| 6.2 | No batch used or shipped before certification | <<FILL>> | <<FILL>> |
| 6.3 | Certification register ready for contemporaneous entry | <<FILL>> | <<FILL>> |
Decision
| Field | Entry |
|---|---|
| All items Pass or justified N/A? | <<FILL: Yes / No>> |
| QP decision | <<FILL: Certify / Hold>> |
| If hold, reason | <<FILL>> |
| QP signature / date/time | <<FILL>> |
References
Regulation (EU) No 536/2014; Commission Delegated Regulation (EU) 2017/1569 (GMP for IMPs). EudraLex Volume 4 Annex 13 and Annex 16 (applied to IMPs); CTR Annex VI (label particulars). Related reading: GMP for investigational medicinal products, QP certification of IMPs SOP.
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
The following shows items 2.4 and 5.2 completed for an example imported batch, so you can see the evidence expected. The values are illustrative.
| # | Item | Pass / Fail / N/A | Evidence ref |
|---|---|---|---|
| 2.4 | Spec, PSF, IMPD, and CoA all agree | Fail | PSF v4.0 tightened related-substance A limit but the IMPD amendment is still pending; certification held pending reconciliation |
| 5.2 | GMP-equivalence assessment on file | Pass | EQ-2026-011 for the US site, approved 20 July 2026 |
In this example the imported-product equivalence passed, but item 2.4 failed because the PSF had been tightened ahead of the IMPD amendment, so the two disagreed. The QP held certification rather than certifying against a spec the dossier had not caught up with. That is exactly the sequence the checklist is meant to force: a disagreement between the PSF and the IMPD is a hold, not a footnote.
Common inspection findings this checklist prevents
- IMP certified before deviations or OOS were closed.
- Certification against an authorisation that does not cover a country or arm.
- Imported IMP certified with no documented equivalence assessment.
- Expiry extension accepted without evidence of the controlled procedure and second check.
- PSF and IMPD out of sync at the moment of certification.
How to adapt this checklist
- Set the batch, trial, and PSF references in the header.
- Mark imported-product items N/A with a justification for EU-manufactured batches.
- Attach a real evidence reference for every Pass; do not mark Pass without one.
- Hold certification on any Fail until it is resolved.
- Confirm every regulation against the current published version before issue.