Storage and transport needs have shifted as the proportion of biologics in biopharm pipelines and portfolios has grown. The IMB guidance addresses this shift by focusing on cold-chain requirements.
“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.
The guidance, which applies to active pharmaceutical ingredients (APIs) and finished products, details the storage and transport steps small and large volume operations should take to maintain the cold-chain.
Differences in the scale of operation impact on recommendations. 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.
The next steps
Differences in scale also shape the transportation guidance. “Larger volumes of cold-chain goods should be shipped in refrigerated transport vehicles, particularly if transit times may be prolonged”, the IMB said. Insulated containers are acceptable for transport of smaller volumes.
After a product is passed on 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 said.
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 to show extremes. Also, products should be kept away from sun-facing windows, fluorescent lights and heaters.