This is a ready-to-use release reconciliation checklist for a combination product whose constituents carry separate manufacturing histories that converge at packaging, a co-packaged kit, a single-entity product with a separately-lotted device component, or any configuration where drug and device evidence must be reconciled before one release decision covers both. It is the working artifact behind the release rule stated in the combination product quality plan, section 6. Replace every <<FILL: ...>> placeholder with your own specifics. Mark each item Pass, Fail, or N/A and route the completed checklist through your normal quality release process. A worked filled specimen follows. Verify each cited regulation against the current source before you rely on it.
Before you start
Confirm which constituents this release decision covers and where their manufacturing histories are recorded, before working the checklist item by item.
| Field | Entry |
|---|---|
| Product name | <<FILL>> |
| Configuration | <<FILL: single-entity / co-packaged / cross-labeled>> |
| Batch / lot number (kit or finished product) | <<FILL>> |
| Drug or biologic constituent lot(s) | <<FILL>> |
| Device constituent lot(s) / serial(s) | <<FILL>> |
| Reviewer | <<FILL>> |
| Review date | <<FILL>> |
Reconciliation checklist
| # | Item | Pass / Fail / N/A | Comment |
|---|---|---|---|
| 1 | Drug or biologic constituent batch record is complete, reviewed, and approved under the drug cGMP base (Part 211, or Parts 600-680 for a licensed biologic). | ||
| 2 | Device constituent history record or device master record evidence is complete, reviewed, and approved under the added or base device provisions (21 CFR 4.4, QMSR / ISO 13485). | ||
| 3 | Drug or biologic constituent meets its release specification (assay, sterility, endotoxin, appearance, potency, as applicable). | ||
| 4 | Device constituent meets its release specification (dimensional, functional / delivery performance, package integrity, as applicable). | ||
| 5 | Stability data supports the labeled expiry of the finished kit or product, driven by the shorter-lived constituent. | ||
| 6 | For sterile products, container closure integrity is demonstrated over the labeled shelf life. | ||
| 7 | Drug or biologic constituent lot number is captured on the kit or finished-product record. | ||
| 8 | Device constituent lot or serial number is captured on the kit or finished-product record. | ||
| 9 | Quantities of each constituent reconciled against quantities issued to the packaging or assembly step, with any discrepancy investigated and closed. | ||
| 10 | Any open deviation, CAPA, or complaint trend against either constituent has been checked and does not implicate this batch or lot. | ||
| 11 | Labeling correctly identifies both constituents where required and matches the approved labeling for the combination product. | ||
| 12 | If this is a co-packaged kit, the assembly or kitting step itself has a completed, reviewed batch record reconciling the constituents brought together. |
Release decision
<<FILL: the release rule for your site, e.g. "No kit ships until all items above are Pass or a documented, dispositioned N/A, both constituent histories are complete, both specifications are met, and lot traceability is complete.">>
| Outcome | Entry |
|---|---|
| All items Pass or justified N/A | <<FILL: Yes / No>> |
| If No, deviation or hold reference | <<FILL>> |
| Release decision | <<FILL: Released / On hold / Rejected>> |
| Quality Assurance approval (name, signature, date) | <<FILL>> |
References
21 CFR 3.2(e) (definition of a combination product) and 21 CFR Part 4 (streamlined cGMP requirements). 21 CFR 211.165 (testing and release for distribution), 211.166 (stability), 211.188 (batch production and control records). 21 CFR Part 820 / the Quality Management System Regulation, aligned with ISO 13485:2016 (device constituent history record expectations). Container closure integrity guidance for sterile products.
Confirm the current version of each reference before issue.
Filled specimen
The following shows the checklist completed for a co-packaged kit: a vial of lyophilized biologic, a prefilled diluent syringe, and a reconstitution needle, assembled into one carton and released as one product. The company, product, and numbers are illustrative.
| Field | Entry |
|---|---|
| Product name | BioLyo Kit, 50 mg |
| Configuration | Co-packaged |
| Batch / lot number (kit) | KIT-2026-0091 |
| Drug/biologic constituent lot(s) | DP-2026-1147 |
| Device constituent lot(s) | Syringe lot SYR-4402, needle lot NDL-8817 |
| Reviewer | R. Nakamura, QA Release |
| Review date | 18 September 2026 |
| # | Item | Result | Comment |
|---|---|---|---|
| 1 | Drug/biologic batch record complete | Pass | Batch record BR-1147 approved, all in-process checks within spec |
| 2 | Device history record evidence complete | Pass | Syringe DHR and needle DHR both closed and approved |
| 3 | Drug/biologic release specification met | Pass | Assay, sterility, endotoxin all within spec |
| 4 | Device release specification met | Pass | Dimensional and delivery-force testing within spec for both components |
| 5 | Stability supports labeled expiry | Pass | Kit expiry driven by lyophilized vial, 24-month stability data on file |
| 6 | Container closure integrity over shelf life | Pass | CCIT data current for the vial-stopper system |
| 7 | Drug/biologic lot captured on kit record | Pass | DP-2026-1147 recorded on kitting batch record |
| 8 | Device lot/serial captured on kit record | Pass | SYR-4402 and NDL-8817 recorded on kitting batch record |
| 9 | Quantity reconciliation | Pass | 5,000 vials, 5,000 syringes, 5,000 needles issued; 4,987 kits assembled; 13-unit variance investigated and attributed to routine line rejects, documented |
| 10 | Open deviation / CAPA check | Pass | No open deviation or CAPA trend implicates these lots |
| 11 | Labeling matches approved labeling | Pass | Carton and insert verified against approved artwork |
| 12 | Kitting/assembly batch record complete | Pass | Assembly batch record KBR-0091 approved |
Release decision: All items Pass. Kit released. Quality Assurance approval: R. Nakamura, signed, 18 September 2026.
Common inspection findings this checklist prevents
- The kit is released on the drug constituent’s record alone, with the device components treated as bought-in stock and never reconciled.
- A quantity variance at kitting is left uninvestigated because no single record forces the reconciliation.
- The labeled expiry is set from the drug constituent’s stability data without confirming the device component’s shelf life actually supports it.
- Lot traceability is incomplete, so a later investigation cannot reconstruct which device lot was paired with which drug lot.
How to adapt this checklist
- Adjust items 3, 4, and 6 to the actual specifications and test methods for your specific constituents; not every combination product has a sterility or CCIT requirement.
- If your configuration is single-entity rather than co-packaged, drop item 12 and confirm which items still apply to your assembly step.
- Set your own release-decision rule in the release decision section to match your quality system’s language.
- Point the References section at your own internal batch record and specification procedures alongside the regulatory citations.