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Abstract
To ensure the quality of raw materials for pharmaceutical products, the right storage and distribution temperature conditions should be applied. Labeled temperature conditions of 539 raw materials at non-cold chain conditions (thus excluding 2-8°C or<0°C conditions) were reviewed that revealed a set of 26 different temperature requirements. From a manufacturer perspective, it is hard or undoable to manage that number of temperature conditions, especially because regulatory guidance towards raw material temperature conditions is lacking. Therefore, the question raised whether it would be possible to define subsets of temperature conditions in order to simplify the storage and distribution management of raw materials. The data set was further analyzed and it resulted in a new storage and distribution model of three temperature conditions for raw materials: 15-25°C, 2-30°C and unrestricted (no minimum and maximum temperature limit). The model can be applied to all non-cold chain raw materials by suppliers and manufacturers in order to harmonize temperature conditions and to manage temperature excursions easier during operations.
Published Version
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