| Increasing legislation surrounding the cold chain storage and shipping of pharmaceuticals means that manufacturers and suppliers need to be more diligent than ever. Geraint Thomas of Laminar Medica assesses the latest generation of temperature-controlled packaging solutions
With pharmaceuticals and related products being distributed over increasingly long distances and through extreme temperature zones, the benefits of sophisticated temperature-controlled packaging solutions have become clear to drug manufacturers and suppliers. Shipments that reach temperatures outside of their acceptable limits often need to be recalled, leading to considerable losses and irreparable damage to valuable client relationships and the distributor’s reputation. In addition to enabling these risks to be minimised, the latest temperature controlled packaging solutions are helping pharmaceutical companies to comply with the growing amount of regulations and legislation now being introduced to ensure the safety and security of the storage and distribution of temperature sensitive drugs.
NEW REGULATIONS
A number of regulations and guidelines relating to the cold chain distribution of pharmaceuticals can now be found in pharmacopoeia and other publications such as The Guide to Good Storage Practice for Pharmaceuticals and The Guidelines on Good Distribution Practice (GDP) of Medicinal Products. These documents contain information on the latest legislation relating to the shipping of temperature-sensitive drugs, detailing the need for effective and standardised packaging and labelling for products, traceable and efficient dispatch processes, and the use of temperature recording devices to determine accurately whether a package has stayed within its acceptable temperature parameters.
According to documents produced by the European Medicines Evaluation Agency (EMEA), it is essential for the safe and secure distribution of pharmaceuticals that subjective terms such as ‘ambient conditions’, ‘room temperature’ and ‘cold’ in product storage and distribution guidelines are replaced with more accurate instructions relating to the acceptable conditions for drugs, and how to act should this environment not be maintained. For a more focused and regulated approach to storing and transporting drugs to be achieved, new and more sophisticated distribution systems are required to ensure that these tighter controls can be maintained. |
