The industry is experiencing an increase in sensitive and sophisticated pharmaceutical, and the compliance with new regulations governing temperature control during processing, storage and transport is on the increase. Any deviation outside the drug stability parameters can have a negative impact on the safety of a patient, which is of significant concern to pharmaceutical companies and regulators alike.

Shipments may experience a range of temperature effects that can impact the stability of a product, leading to temperature excursions that cause the product to become unfit for patient administration. Steps must therefore be taken to reduce the risk of these and to have the data to support adjudication of the product.

Air, land and sea freight each experience different variables that can affect temperature and each mode of shipping has its own risks in regard to cost, climate, time and storage locations. Therefore risk- based strategies must be applied when identifying and selecting transportation routes.
Comprehensive, Good Distribution Practice (GDP) means compliant monitoring of all temperature controlled materials is essential throughout all shipments. The most appropriate method to ensure all relevant information is captured is to include a temperature monitor which collects essential primary data, offering accurate readings correlating to specific dates and times during transit and storage.

Learn more about these necessary steps in our informative article written by Almac’s Heather Bogle, Supply Chain Solutions Manager which was published in the International Pharmaceutical Industry (IPI) magazine.

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