Cold-Chain Shipping Checklist

What must the shipping plan protect?

Choose the complete arrangement against approved product conditions. Ask the owner for written limits and the evidence needed at receipt. This checklist does not establish a universal temperature band or certify a Zenith shipment.

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Reference: WHO: product stability and transport guidance

Keep food and pharmaceutical requirements distinct

For food, request the supplier’s handling specification and food-safety controls for the actual product, including hygiene, segregation and shelf-life considerations. Codex lists General Principles of Food Hygiene, CXC 1-1969, as a food-hygiene reference; it is not proof of a logistics company’s certification.

For pharmaceuticals, obtain manufacturer-approved conditions, product identity, applicable authorisations and the quality agreement. WHO storage/distribution guidance supports traceability and documented responsibilities. It does not make every WHO recommendation a legal obligation in every country or establish that Zenith, a partner or a facility holds GDP status.

Location example, reviewed 13 October 2026: the United States FDA sanitary-transport rule covers specified food movements by motor or rail, subject to its exclusions and waivers. Its scope is not a worldwide rule for ocean or air carriage. Confirm the actual origin, transit and destination requirements with the importer and qualified regulatory or food-safety specialists.

Reference: Codex: current codes of practice directory · WHO: good storage and distribution practices · FDA: United States sanitary-transport scope

Check the configuration and every handover

Ask whether qualification evidence covers the intended packaging configuration, payload and exposure profile. Qualification means documented evidence that the system performs for its defined conditions; a report for a different pack-out is not automatically applicable. WHO’s shipping-container supplement explains a structured qualification approach for pharmaceuticals.

Ask how the plan deals with collection readiness, terminal holding, inspection, connection delays and receiving appointments. These questions identify gaps between the main transport legs. A suitable vehicle does not by itself establish that transfer storage or an inspection area can maintain the required condition.

• Confirm who prepares the product and packaging under the approved instructions.
• Record transfer locations, planned exposure limits and available controlled-holding arrangements.
• Check coolant, battery or other regulated components with the carrier where used.
• Define permitted contingency actions and an escalation contact; do not improvise a new pack-out.

Reference: WHO: qualification of shipping containers

Specify the evidence, then the response

A data logger records exposure; connected monitoring may also communicate data during transit where the selected system supports it. Specify calibration status, identifiers, placement, recording settings and how records will be obtained. WHO’s monitoring supplement distinguishes device capabilities and addresses collection, storage and retrieval of data.

Agree who checks the records, receives an alert and applies the hold procedure. Monitoring is useful evidence, but it is not an automatic product-release decision. WHO distribution guidance calls for written procedures and reporting of deviations. Product acceptance or disposal needs the designated authorised decision-maker.

• Do not assume a delivery signature confirms temperature compliance.
• Do not describe a download-only logger as live tracking.
• Do not accept “refrigerated” as a substitute for written product limits.
• Do not treat one qualification report as evidence for every season, payload or journey.

Reference: WHO: transport monitoring systems · WHO: deviations, records and responsibilities

Hypothetical example: a medical-product shipment

A distributor has a product-owner transport instruction but no approved packaging configuration for the consignment. The buyer shares the instruction, payload and arrival window, then requests review of packaging evidence, transfer conditions and monitoring. The quality owner approves the configuration and reviews exceptions. This hypothetical example assumes no temperature range, route, successful outcome or Zenith certification.

Documents and information for a cold-chain quote

Attach the product transport instruction, packaging specification and available qualification evidence. Include relevant safety/classification information and the monitoring or quality agreement if already established. Request a quotation that identifies the thermal-control scope, evidence to be delivered and any unresolved acceptance conditions.

• Product identity, presentation, regulatory category, quantity and package dimensions/mass.
• Approved transport range, exposure limits, exception rules and release authority.
• Collection and delivery addresses, shipment window, receiving hours and transfer constraints.
• Pack-out or equipment needs, payload configuration and coolant details where applicable.
• Monitoring, report format, handover records, storage and contingency requirements.