G_IPC_34 Maintaining the Cold Chain

 

Medicinal products should be stored and transported under conditions which ensure that their quality is maintained. Maintenance of the cold-chain is required for both the storage and transportation of some medicinal products.

There is an increasing number of medicinal products requiring controlled storage and transit conditions. Among the cold-chain items are high risk products such as vaccines, insulins, blood products and other proteinaceous materials, which normally require storage between 2°C and 8°C. These products must be protected from freezing; even a brief period at sub-zero temperatures may irreversibly denature the protein, leading to a loss of efficacy. There are also products such as emulsion systems and solutions of sparingly soluble components which may become physically unstable at sub-zero temperatures.

At every point in the chain precautions should be taken to minimise the effect of adverse external conditions on the quality and stability of that product. Where relevant, records should be maintained to provide evidence of compliance with the labelled storage recommendations for those in whose care the product is at the time and to other interested parties who may seek this assurance, such as the recipient and/or marketing authorisation holder.

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