GDP & Cold Chain Readiness Checklist
A practical, audit-oriented checklist for evaluating whether a facility or partner genuinely meets Good Distribution Practice and cold chain standards
Purpose
Use this checklist to evaluate a warehousing and distribution operation — your own or a prospective partner’s —
against the standards that define a credible GDP and cold chain capability. Each item is phrased so that a confident
“Yes, and here is the evidence”
is the only acceptable answer in a healthcare context. A “yes” without documentation is a “no.”
Tick each item:
✅ Verified with evidence · ⚠️ Claimed, not evidenced · ❌ Not in place
Section A — Quality Management System & Certifications
☐ A documented Quality Management System (QMS) governs processes, procedures, and responsibilities.
☐ ISO 9001 certification is held and current.
☐ GDPMDS certification is held (for medical device distribution), with scope confirmed.
☐ ISO 13485 certification is held where value-added work (relabelling, repackaging) is performed on devices.
☐ HSA GDP certification / wholesale dealer licensing is held where therapeutic products are handled (Singapore).
☐ Certification scope matches the specific product classes to be handled.
☐ The facility maintains audit readiness and can support customer or regulator audits.
Section B — Temperature Capability & Segregation
☐ Ambient storage (temperature-monitored) is available.
☐ Controlled room temperature (18–25 °C) storage is available at adequate pallet capacity.
☐ Refrigerated / chiller (2–8 °C) storage is available.
☐ Dedicated chiller capacity for controlled drugs(with added security) is available where required.
☐ Frozen (−10 to −25 °C) storage is available.
☐ Ultra-low-temperature (−80 °C) storage is available where required.
☐ Radioactive-licensed storage is available where required.
☐ Equipment redundancy ensures a single unit failure does not cause product loss.
☐ Stock is segregated by status (quarantine, released, rejected) and by class (controlled, radioactive).
Section C — Monitoring & Data Integrity
☐ 24/7 temperature monitoring via validated systems is in place.
☐ 24/7 relative humidity monitoring is in place.
☐ Monitoring includes alarming to trigger intervention before loss.
☐ Continuous data logging produces an unbroken, auditable record.
☐ Historical temperature/humidity records can be produced on request .
Section D — Cold Chain in Transit
☐ Transport lanes are validated for the specific products and packaging carried.
☐ Passive/active solutions are matched to payload duration and ambient exposure .
☐ Cross-border lanes (where applicable) are qualified for the full transit duration, including customs dwell.
☐ A documented excursion management procedure detects, quarantines, assesses, and dispositions affected stock.
☐ End-to-end traceability is maintained from dispatch to delivery.
Section E — Security, Access & Environment
☐ Security and access control restrict entry by zone.
☐ CCTV surveillance and/or biometric/controlled entry provide a verifiable access record.
☐ Heightened controls protect controlled drugs and radioactive materials .
☐ A standing pest control management program is in place.
☐ Facility maintenance and cleaning are performed to documented standards.
Section F — Systems & Technology
☐ A Warehouse Management System (WMS) governs locations, stock status, and movement.
☐ An ERP system integrates inventory with orders, invoicing, and reporting.
☐ RF scanning captures data at receiving and picking for accuracy and turnaround.
☐ Systems provide real-time visibility across the supply chain.
Section G — Value-Added Capability
☐ A controlled, certified redressing/relabelling room is available (with defined temperature control and changing/gowning area).
☐ Repackaging, relabelling, and kitting can be performed under appropriate certification.
☐ Value-added work on devices is performed under ISO 13485 / GDPMDS conditions.
Interpretation
Count your ✅ (verified) items only. Claimed-but-unevidenced (⚠️) items should be treated as risks until documented.
- Mostly ✅ across all sections: A genuine, audit-ready GDP and cold chain operation. Proceed with confidence; focus diligence on scope-matching for your specific products.
- Strong A–C, weak D: Good at-rest capability, but in-transit integrity is unproven — the most common and most dangerous gap, because product spends a vulnerable fraction of its life in motion.
- Many ⚠️ items: The operation may be capable but cannot yet prove it. In healthcare, unprovable compliance is non-compliance. Require evidence before committing product.
- ❌ in A (certifications) for your product class: A disqualifying gap — the operation cannot lawfully handle your product, regardless of other strengths.
The Single Most Important Question
If you ask only one thing, ask this:
“Show me a continuous temperature record for a product like mine, including any excursion and how you dispositioned it.”
The answer reveals everything at once — whether monitoring is real, whether data is auditable, whether excursions are governed by a quality decision rather than a guess, and whether the operation tells you the comfortable story or the true one. A partner who can answer this calmly, with documentation including a real excursion and its resolution, is demonstrating mature GDP. A partner who claims they “never have excursions” is demonstrating that they are not measuring.
This checklist supports structured due diligence. A full facility assessment — conducted on-site, against your specific product classes and temperature requirements — converts these checks into a documented qualification of your supply chain partner.