This is a ready-to-use self-inspection checklist for a warehouse and distribution operation, built around the seams an experienced GDP inspector actually probes. Score each item Pass, Fail, or N/A with evidence, and route every Fail to CAPA. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Checklist control
| Field | Entry |
|---|---|
| Checklist number | <<FILL: CHK-ID>> |
| Site / operation | <<FILL>> |
| Inspection date | <<FILL>> |
| Inspector(s) | <<FILL>> |
| Parent SOP | <<FILL: SOP-ID for GDP>> |
1. Temperature mapping and monitoring
| # | Item | Ref | Result (P/F/NA) | Evidence / finding |
|---|---|---|---|---|
| 1.1 | A current mapping report exists for each controlled storage area | Annex 15 / GDP | <<FILL>> | <<FILL>> |
| 1.2 | Permanent monitors sit on the worst-case locations the mapping identified | Mapping report | <<FILL>> | <<FILL>> |
| 1.3 | Mapping is current against the latest layout, racking, and HVAC | Change control | <<FILL>> | <<FILL>> |
| 1.4 | Monitors are calibrated with traceable certificates | Metrology | <<FILL>> | <<FILL>> |
| 1.5 | Alarms reach a person who can act, and alarm response is recorded | GDP | <<FILL>> | <<FILL>> |
2. Shipping lane qualification
| # | Item | Ref | Result | Evidence / finding |
|---|---|---|---|---|
| 2.1 | A qualified packaging-and-lane record exists for every route in use | Annex 15 / GDP | <<FILL>> | <<FILL>> |
| 2.2 | Qualified transit time meets or exceeds the carrier’s real transit time | Lane matrix | <<FILL>> | <<FILL>> |
| 2.3 | Worst-case season is covered (summer and winter, or documented rationale) | Lane qualification | <<FILL>> | <<FILL>> |
| 2.4 | Pre-conditioning of coolant is performed exactly as qualified | Pack-out WI | <<FILL>> | <<FILL>> |
| 2.5 | Carriers are contractually bound to the qualified transit limits | Quality agreement | <<FILL>> | <<FILL>> |
3. Excursion management
| # | Item | Ref | Result | Evidence / finding |
|---|---|---|---|---|
| 3.1 | Excursions trigger quarantine before disposition | GDP / deviation | <<FILL>> | <<FILL>> |
| 3.2 | Dispositions use magnitude, duration, MKT, and cumulative budget, not a blanket statement | Stability data | <<FILL>> | <<FILL>> |
| 3.3 | Cumulative excursion budget is tracked across legs on the lot record | GDP | <<FILL>> | <<FILL>> |
| 3.4 | Freeze excursions on cold-side-zero products default to reject | Stability data | <<FILL>> | <<FILL>> |
| 3.5 | Dispositions are signed and dated by quality (RP or delegate) | GDP | <<FILL>> | <<FILL>> |
4. Named accountability
| # | Item | Ref | Result | Evidence / finding |
|---|---|---|---|---|
| 4.1 | A Responsible Person (or equivalent) is named and independent of commercial pressure | GDP / WDA | <<FILL>> | <<FILL>> |
| 4.2 | A delegation chain covers the role during absence | GDP | <<FILL>> | <<FILL>> |
| 4.3 | The RP demonstrably signs excursion dispositions and recall decisions | Records | <<FILL>> | <<FILL>> |
5. Returns and recall
| # | Item | Ref | Result | Evidence / finding |
|---|---|---|---|---|
| 5.1 | Saleable returns meet the demonstrable-storage, intact-packaging, in-date, verifiable-identifier gates | GDP / DSCSA | <<FILL>> | <<FILL>> |
| 5.2 | Unmonitored returns are treated as non-saleable by default | GDP | <<FILL>> | <<FILL>> |
| 5.3 | A recall can reach the consignee level with shipped-vs-retrieved reconciliation | GDP | <<FILL>> | <<FILL>> |
| 5.4 | Recall effectiveness has been tested (mock recall) | GDP | <<FILL>> | <<FILL>> |
6. Serialization integrity
| # | Item | Ref | Result | Evidence / finding |
|---|---|---|---|---|
| 6.1 | Product identifiers are commissioned and aggregated without duplication or orphaning | DSCSA / FMD | <<FILL>> | <<FILL>> |
| 6.2 | The aggregation hierarchy matches the physical pallet | Serialization | <<FILL>> | <<FILL>> |
| 6.3 | DataMatrix print grade is monitored in process against the minimum grade | ISO/IEC 15415 | <<FILL>> | <<FILL>> |
| 6.4 | The serialization system is validated with ALCOA+ controls on its data | GAMP 5 | <<FILL>> | <<FILL>> |
Scoring and sign-off
| Field | Entry |
|---|---|
| Total items / Pass / Fail / NA | <<FILL>> |
| Fails routed to CAPA (numbers) | <<FILL>> |
| Overall verdict | <<FILL: acceptable / conditional / not acceptable>> |
| Role | Name | Signature | Date |
|---|---|---|---|
| Inspector | <<FILL>> | ||
| RP / Quality Head | <<FILL>> |
Filled specimen
Illustrative extract from a cold-chain warehouse self-inspection.
| # | Item | Result | Evidence / finding |
|---|---|---|---|
| 1.2 | Monitors on worst-case locations | Fail | Permanent probe mounted at eye level near door; mapping identified the true hot spot at CR-07 (dock-door top rack), unmonitored. CAPA-DIST-2026-021 |
| 2.2 | Qualified transit vs real transit | Fail | Shipper qualified for 72 h; carrier scan history shows a 90 h leg on the Hub A to Hub B lane. CAPA-DIST-2026-022 |
| 3.4 | Freeze defaults to reject | Pass | Excursion SOP and two worked dispositions confirm freeze-first logic |
| 4.1 | RP named and independent | Pass | R. Okafor, RP on WDA; reports to Quality, not Commercial |
| 6.2 | Aggregation matches physical | Pass | Sampled 5 pallets, parent-child intact on scan |
The two Fails are the classic GDP findings: a monitor placed for convenience rather than on the mapped worst case, and product moving on a shipper qualified for less time than the carrier actually takes. Both are routed to CAPA with the evidence attached.
Common findings this checklist surfaces
- Permanent monitors not on the mapped worst-case zones.
- Product shipped on unqualified lanes or on shippers qualified for a shorter transit than reality.
- Excursions released on a blanket stability statement with no cumulative-budget math.
- No named, independent, available decision-maker signing dispositions.
- Serialization aggregation errors, duplicate or orphaned serials, or sub-grade print not caught in process.
How to adapt this checklist
- Set the site and parent SOP in the control block.
- Add rows for any modality-specific control (for example, deep-frozen or cryogenic handling).
- Route every Fail to a CAPA number in the scoring block.
- Confirm the current references before you rely on them; this is educational guidance, not regulatory advice.