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.

为确保药品原料的质量，应采用合适的储存和配送温度条件。审查了 539 种原材料在非冷链条件下（因此不包括 2–8 °C 或 < 0 °C 条件）的标记温度条件，揭示了一组 26 种不同的温度要求。从制造商的角度来看，管理如此多的温度条件很难或无法实现，尤其是因为缺乏对原材料温度条件的监管指导。因此，提出了是否可以定义温度条件的子集以简化原材料的存储和分配管理的问题。对数据集进行了进一步分析，得出了原材料三种温度条件的新存储和分配模型：15–25 °C、2–30 °C 和不受限制（没有最低和最高温度限制）。该模型可以应用于供应商和制造商的所有非冷链原材料，以协调温度条件并在操作过程中更容易地管理温度偏移。