MHRA博文：温度分布试验 ---介绍

原文：https://mhrainspectorate.blog.go ... ng-an-introduction/

Temperature mapping – an introduction. 温度分布试验 ---介绍

Steve Todd, 14 July 2016 — Compliance matters, Good distribution practice

GDP Guidelines Chapter 3.2.1 GDP指南第3.2.1章

“An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions.

“存贮区域在使用前应在具有代表性的条件下进行初始的温度分布试验。”

Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations.

温度监测设备应根据温度分布试验的结果定位，保证监测装置被放置在极端波动的区域。

The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment.

应根据风险评估的结果，或者当对设施或温度控制设备有重大改造时，应重复温度分布试验。

For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be conducted and temperature monitors placed accordingly”.

对于较小的设施，只有几个平方米时，放置在常温下，应进行可能的风险（例如加热器）评估，并相应地放置温度监测器。

It has become apparent during inspections that some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines.

很明显，在检查中有一些公司并不清楚如何来符合GDP指南里的这些要求。

This seems particularly apparent with new applicants and those companies with small storage areas, possibly a few shelves or small refrigerators, to which this blog is particularly aimed.

这看起来尤其明显，新的申报者和那些有较小存贮区域的公司，可能会有较少的货架或较小的冰箱，这种情况下此博文尤其适用。

Some larger storage areas may employ the expertise of a third party company specialising in this area.

一些较大的存贮区域可以使用第三方公司在此领域的专家。

Guidelines say that mapping should take place, but it does not state how this should be done.

指南说温度分布是需要做的，但并没有说要如何做。

Why map? 为什么要做温度分布试验?

To demonstrate by way of documented evidence that the chosen storage area is suitable for the storage of temperature sensitive medicinal products.

为了采用有文件记录的证据的方式证明所选择的存贮区域是适用于温度敏感药品的存贮的。

As stated in one of my previous blogs, ambient products are also temperature sensitive.

在我之前的一篇博文中曾说过，室温药品也是温度敏感的。

A mapping exercise of the proposed storage area will ensure that the company will understand their storage area and identify any potential areas therein that may be unsuitable to store medicines.

所拟存贮区域的温度分布试验将保证公司能了解他们的存贮区域，识别出所有可能不适合存贮药品的区域。

A mapping exercise will also inform as to where permanent thermometers should be located.

温度分布试验也要说明是否需要放置永久性温度计。

When to map. 什么时候做温度分布？

If possible, before stock is stored.

尽可能在开始存货前做。

This might not be possible where a storage area is being reconfigured.

如果存贮区域要重新设置的话，可能无法做到。

In smaller empty storage areas, dummy products could be used to simulate normal operational storage without compromising genuine product, including cold stores and fridges/freezers.

在较小的空的存贮区域，可以用填充物来模拟正常的操作存贮，而不需要使用真的药品，包括冷冻存贮和冷藏。

In an empty storage area, a mapping exercise should be repeated when fully stocked.

在空的存贮区域里，如果存贮全满的话则要重复温度分布试验。

Data arising from the exercise should be documented and a risk assessment documented with any hot or cold spots identified.

从温度分布试验中获得的数据应记录，同时要记录风险评估，并识别出最高温和最低温度点。

This exercise should then be repeated to take into account seasonal variations.

在考虑季节波动后，还要重复此试验。

How to map. 如何做分布测试

Firstly, look at the area to be used for storage, identify the highest point of storage not the highest shelf or pallet location.

首先看一下要用于存贮药品的区域，识别出存贮的最高点，不是最高位的货架或托盘。

Identify any potential problem areas such as heaters, lighting, windows and doors, loading bays or high storage areas such as mezzanine floors. These areas should be covered in the exercise.

识别出所有可能有问题的区域，如加热器、照明、窗户和门、装货台或高存贮区域，如夹层间。这些区域应包括在温度分布试验中。

Don’t forget to include areas such as CD rooms, packing areas, Returns and quarantine.

不要忘记了包括一些区域，如CD间、包装间、退货间和待验间。

When deciding on a storage area, remember, it can be difficult to cool storage areas down as well as heat them up.

如果决定一个存贮区域，记住，可能很难将存贮区域冷却下来以及升高其温度。

Use calibrated monitoring probes in sufficient numbers dependant on the size of the storage area.

根据存贮区域的大小，使用足够数量的经过校正的监测探头。

Risk asses the data. 数据的风险评估

Once the initial mapping exercise is complete, the data should be recorded and risk assessed to determine the most appropriate positions for the permanent monitoring probes and should cover the areas that have the widest temperature fluctuations or indicate areas with any hot or cold spots.

一旦完成了初始的温度分布试验，应记录数据，进行风险评估，确定永久性监测探头应放置的最适当的位置，并且要覆盖最大温度波动的区域，或者是最高最低温度点。

Repeat the exercise to cover seasonal variations or if the storage area is subsequently reconfigured.

重复试验以覆盖季节波动。当之后存贮区域重新设置时需要重复试验。

A risk assessment would also define and justify the regularity of any future mapping exercises and must also be regularly reviewed, perhaps as part of the self-audit process.

风险评估还需要界定并论证未来温度分布试验重复的频次，还必须进行定期审核，可能是作为自检程序的一部分。

Responsible Person. 责任人

The RP should be party to the whole mapping process and should be fully aware of the mapping exercise findings, risk assessment recommendations and review process.

责任人应该是整个温度分布试验的负责人，应该完全明白温度分布试验的问题、风险评估建议和审核流程。

The RP involvement does not stop at the mapping process however.

责任人的干涉并不会停止温度分布试验过程。

The RP should also be able to demonstrate supervision and review of subsequent daily minimum/maximum routine temperature monitoring and recording and should be consulted in the event of any temperature excursions.

责任人还应该能够证明监管和审核之后的日常最少/最多日常温度监测和记录，当有温度超出范围时应参考这些数据。