Irish guidance for pharma cold chain

Dublin, Ireland: The Irish Medicines Board has published guidance for cold-chain storage and transport of active pharmaceutical ingredients and finished products.

The guidance details the cold-chain storage and transport requirements for small and large volume operations, when storing products at a small site, businesses should know how repeatedly opening and closing a door affects temperature.

For larger sites, the use of walk-in cold rooms creates other issues.  The air temperature distribution inside the room should be mapped in empty and full conditions.  Areas shown to present a risk of deviation from the target temperature should be kept clear of products.

Both small and large volume operations should have procedures to promptly tell the responsible person of temperature deviations.  Investigations into the deviation must be documented.

Even a brief period at sub-zero temperatures may irreversibly denature protein and lead to a loss of efficacy, and therefore such medicinal products must be maintained within a narrow temperature range above freezing point throughout the distribution chain”, the IMB said.

“Larger volumes of cold-chain goods should be shipped in refrigerated transport vehicles, particularly if transit times may be prolonged”, the IMB says.

Insulated containers are acceptable for transport of smaller volumes.

After a product is passed to the next player in the chain, the wholesaler still has responsibilities.  Processes should be in place to guarantee conditions are maintained when the product has left the wholesalers control.  Inability to do so affects acceptance of returns.  “The IMB policy is that cold-chain products may only be returned to saleable stock where there is no reasonable possibility that the cold-chain has been compromised”, the guidance says.

A small section of the guidance covers products without cold-chain requirements.  These products must avoid extremes of hot and cold, such as above 25ºC and refrigeration, but a wide range of temperatures is acceptable.

Despite the less stringent temperature requirements, precautions are still needed.  The warehouse should be temperature mapped in winter and summer.