Basically, there are no requirements that all transports must be carried out in a temperature-controlled manner. The only requirement from the GDP directive is that the permitted storage conditions must also be observed during transport. Risk-based approaches can also be used for this by collecting data during transport in winter or summer with loggers. Here the maximum deviations are determined. If further stability data are available for the products, deviations from the storage conditions may also be justified. It should be noted, however, that a trend towards fully temperature-controlled transport is noticeable at Swissmedic.
Dr. Katharina Oehler
Scientific and Managing Director
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