Cold Chain
Reception and Cold Chain Verification

The arrival of a vaccine shipment in a country, and its subsequent clearance through customs and transportation to the central vaccine store are the most critical stages in the shipping process. These are frequently the times when mistakes and delays occur, resulting in damage to the vaccines.

Reception at Customs

Regarding the customs clearance of the vaccines, the same procedures as described in the Customs topic apply, but with additional specific requirements linked to vaccine management. Note that requirements vary from country to country.

The first step in the customs clearance process, is contacting the following entities to obtain or verify the import procedures:

  • National regulatory authorities (NRA) or head of customs in the destination country. To be cleared, the vaccines must have received marketing authorisation and a release certificate from the national regulatory authority.
  • Local Ministry of Health (MOH): depending on country specific requirements, the MOH may issue a letter approving the shipment.

As reference, the general steps are:

  • Submission of vaccine shipping documents (as soon as they are received) with a request to customs authority for the provisional clearance of shipment to the nominated Clearing and Forwarding (C&F) agent.
  • C&F agent immediately processes the shipping documents as per established rules and regulations of government and contacts customs and airlines to coordinate the arrival, transport, checking and safe storage of the vaccines.
  • Continuous contact is maintained well in advance with the concerned airlines to get accurate and updated information of the flight arrivals of the shipments.
  • Once the flight arrives, immediate action is taken to release and take delivery of the vaccine shipment and to safely transport the vaccines to the cold storage locations.
  • C&F agent checks the cold-chain monitor(s) and other mechanism (if necessary) to identify and reconfirm that the vaccines arrived in good condition before removing the shipment from the airport.
  • Irrespective of the condition of the vaccines at the time of clearance, the C&F agent clears the vaccines and delivers as per regular procedures.
  • The C&F agent informs the concerned official(s) in a timely manner and arranges for the cold room and the required staff to be ready and available to receive/store the vaccines.
  • There should be a system in place to arrange to open the cold room and liaise/contact with the store keeper/cold room staff at any time (24-hours/day, including weekends and holidays).
  • Under no circumstances can any vaccine be left unattended, or outside of the cold room in an open space.
  • Unannounced shipments are cleared in time, like all other shipments.
  • A reliable transport system including a refrigerated/insulated van should be made available at all times for effective transportation and delivery of the vaccines.
  • In emergencies, the use of charter flights is very common. There are separate rules, regulations, systems and procedures for clearance of charter flights with vaccines including obtaining special permission for landing, fly over etc. and various no objection certificates (NOCs) from Ministry of Civil Aviation, etc.

Importing vaccines through ports that don’t have the adequate cold storage facility is not recommended. In the event of receiving a shipment of vaccines needing clearance in a port without cold storage facility or if the cold room is inaccessible, arrangements should be done for immediate release of the vaccine shipment. Coordination with the relevant authorities for an agile clearance and/or for safe and appropriate management and storage of vaccines at the airport are therefore needed.

Reception at the Storage Facility 

Previous to reception make sure that a copy of the freight documents is available. Refer to the information about “Documentation” above.

Ensure priority unloading. Remove product from the vehicle and check that the number of boxes matches the number of boxes shown in the packing list. If it does not, note it conveniently in the provided waybill. Also indicate in the waybill if the shipping boxes were received in good condition and if all necessary labels on the outside of the shipping boxes were present.

Move the product immediately to the storage facility.

Open packaging, retrieve and inspect the temperature monitors, remove product from its passive shipping container and move it immediately to the correct temperature-controlled storage conditions.

If the temperature monitor (whichever is used: Cold Chain Monitor Card, Vaccine Vial Monitor, Electronic Temperature Indicators or Electronic Data Logging Monitors) shows a change that indicates potential damage to vaccines, take a picture, photocopy or scan that show alarm status. This information should be used to make decisions on whether to accept the product, or whether to quarantine it until an investigation has taken place and a final disposition has been made.

If using data loggers or tags that record time and temperature data that can be downloaded, retrieve and store conveniently time and temperature data. The point in time when a temperature excursion has occurred is important for the purchasing agency and the manufacturer so they can identify the cause of the excursion, take corrective measures, avoid similar situations in future shipments, and for insurance purposes.

Clearly identify vaccines in boxes in which the indicator shows exposure to temperatures that risk damage and keep them at the required temperature for further assessment of their condition. Do not discard vaccines until assessment is completed.

Verify that all necessary documents are present. Do not use the vaccines if the lot release certificate is missing. In that case, keep vaccines on hold in cold storage until the relevant document has been obtained from the vaccine manufacturer.

Report any relevant information to the carrier and to the appropriate personnel in your organisation. In case of loose or damage review insurance policy clauses and follow the insurance claim instructions.

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