如何实施温度分布试验

GMP News
08/08/2016

How to perform Temperature Mapping

如何实施温度分布试验

In a recent blog of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the inspectorate looks at temperature mapping. It seems that 'some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines', the Agency says.

在英国药监最近的博文中，检查员查看了温度分布试验。当局说，看起来“有些公司并不清楚如何做来符合GDP指南里的这些要求”。

The requirement itself is defined in the GDP Guidelines Chapter 3.2.1: 'An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions.' The results of this mapping should be used to place monitoring devices at areas that experience the most temperature differences and the hot and cold spots. Any potential area that may be unsuitable to store medicines should be identified. Therefore, mapping should be performed before stock is stored. However, the MHRA also recommends to repeat the mapping when the storage area is operating (taking into account seasonal variations).

要求本身是在GDP指南第3.2.1里定义的，“存贮区域在使用之前要在代表性条件下进行初始温度分布测试”。此分布测试的结果应被用来布置该区域的监测装置，所布的监测点应有最大的温度差异，应包括最高和最低温度点。所有可能不适用存贮药品的区域都要被识别出来。因此，分布试验的实施应该在用于存放药品之前。但是，MHRA也建议在存贮区域运行中时重复温度分布试验（考虑季节波动）。

What to consider: 要考虑些什么：

• Identify crucial storage areas: highest point of storage, heaters, coolers, lighting, windows, doors, loading bays etc.

• 识别出关键的存贮区域：存贮最高温点、加热器、致冷器、照明、窗户、门、装载区等

• Use calibrated monitoring devices in sufficient numbers

• 使用足够数量的校正过的监测装置

• Record and assess da

  ta

• 记录和评估数据

• Repeat mapping to cover for seasonal variations or if the storage area is (subsequently) reconfigured

• 重复温度分布试验以覆盖季节性波动，或者是当存贮区域（在之后）重新设置的话