How to define the right ambient temperature range for storage and distribution of pharmaceutical raw materials.

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.