Refrigerated Medicinal Products – what to consider…

by | Jul 13, 2021 | Blog, Export Training, Good Distribution Practice - GDP

How do you manage YOUR refrigerated medicinal products?  Are you shipping refrigerated medicines effectively?

Check out 10 key points to making your business safe:

  1. Refer to the EU GDP Guidelines 2013 and the Green Guide.  This is the law so adhere to it!
  2. Pack refrigerated products to ensure that the required temperatures are maintained throughout the journey.
  3. Transport product in accordance with labelling requirements to prevent jeopardising quality.
  4. Containers should be well labelled with:
    • handling and storage requirements
    • contents and source
  5. A validated insulated container can be used for small volumes of low risk products where the journey time is less than 3 hours
  6. Use of carefully placed gel or ice packs can be used for longer journeys. Ensure you position ice packs carefully: they must not come into direct contact with the products .
  7. Consider using specialist packaging with compartments for gel or ice blocks, although secure wrapping in bubble wrap, or some other form of a buffer between the ice block and the product can be equally effective.
  8. Ensure you have evidence that the required temperatures can be maintained whichever method you use.  PROOF IS KEY!
  9. Best practice is routine temperature monitoring for all refrigerated deliveries.  The temperature should be strictly controlled and monitored with calibrated temperature probes, to provide temperature data for the entire journey.
  10. AS A MINIMUM… Daily minimum and maximum temperature monitoring and recording should also be carried out at all storage locations. Any recording devices should be calibrated annually.

This information can be read in full in the MHRA Inspectorate article written by Simon Todd

To learn more about these, and other requirements, have a look at our training offerings here

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