欧盟GDP对运输的温度要求应如何理解

julia朱玉姣

GDP: Is Temperature Control required for each Transport?
GDP:是不是每次运输均需要对温度进行控制？

The EU Good Distribution Practice (GDP) Guidelines (2013/C 343/01) revised in 2013 reflect the requirements and expectations of the authorities during the transport and distribution of medicinal products in a very detailed way. Nevertheless, there are still questions and insecurities.
2013年修订后的欧盟GDP指南（2013/C343/01）以非常详细的方式反映了官方对于药品运输和销售的期望和要求。不过，还是有一些问题不太清楚。

Especially questions on temperature control during transport are recurring. This question is examined in detail in a corresponding questions and answers paper of the German ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten/ Central Authority of the German Federal Länder for Health Protection Regarding Medicinal Products and Medical Devices) (in German language).
特别是关于运输途中的温度问题再次被提出。这个问题在“德国ZLG问答”中有了一些详细的解答，不过是德文的。（据德国同事介绍，ZLG是德国药品和医疗器械负责审批类的机构）

Here, it is stated that a temperature control is not required for each transport:
其中说明了并不是每一次运输中都要求对温度进行控制：
"If no constant monitoring of temperature is carried out during the transport of medicinal products a risk assessment must be made of the transportation routes. This includes especially the travel duration including special aspects of the route, the time of year and day, including the weather forecast, the vehicles used and their equipment. The results of this risk assessment have to be part of the transportation planning."
“如果在药品运输中没有实施持续的温度监控，则必须对运输路线进行风险评估。评估特别要包括运输时间，包括路线的特殊问题，季节和天数，包括天气预报，所用的货车及其装备。该风险评估的结果必须成为运输计划的一部分。”
But at the same time this means that monitoring has to be done if no risk assessment was carried out or if the risk assessment led to the result that a temperature control is necessary.
但同时，这也表示如果没有进行风险评估，那就必须进行监控，或者如果风险评估结论是需要对温度进行控制，那也必须进行监控。
According to the ZLG document a lot of things have to be considered when carrying out the risk assessment:
根据ZLG文件，在进行风险评估时必须要考虑很多问题：
•        The mean kinetic temperature (MKT) cannot be used. The reason is that it does not take into consideration effects "that may lead to irreversible quality defects even when certain temperature limits that are established during stability studies in connection with the marketing authorisation are exceeded only for a short time. And it does not take into consideration the possible formation of fissures in the glass of ampoules and injection bottles at temperatures around the freezing point. Furthermore, calculation of the MKT requires that the temperature profiles of all transports are known that have been carried out previously. But usually this data is not available ...."  
•        不能使用平均动力学温度（MKT）。理由是它没有考虑到影响“可能会引起不可逆的质量缺陷，即使在稳定性研究期间已建立了与上市许可相关联的特定温度限度只是超出了很短的时间。它没有考虑在冷冻点上下的温度可能会使得安瓿和注射用瓶的玻璃产生龟裂。另外，MKT计算需要知道之前已实施的所有运输过程中的温度概况。但通常这些数据是无法获得的……”
•        In order to assess deviations "appropriate procedures" must be established.  
•        为了评估偏差，必须建立“适当的程序”
•        Storage conditions must generally be respected also during transportation. "Only in cases that according to the packaging or the confirmed written information given by the manufacturer, the pharmaceutical entrepreneur or the marketing authorisation holder. a transport within the aforementioned temperature range will not reduce the quality" this temperature range can be handled more generously. It has been demonstrated for example "in connection with the marketing authorisation of medicinal products on the labelling of which only storage between +2 and +8 °C is indicated that they remain sufficiently stable even if the temperature rises up to +25 °C for a short time."
•        在运输过程中必须遵守存贮条件。“只有当根据生产商、药品企业或上市许可持有人提供的包装或确认的书面信息，在上述温度范围内的运输将不会降低质量”，这样的温度范围才可能更灵活。例如，已证明“与药品上市许可相关的标签说明只能存贮在+2到+8 °C，即使温度在短时间内高至 +25 °C其质量仍保持足够稳定。

julia朱玉姣

将于近期问德国同事拿到该份问题，还请懂德文的战友关注

孙艳红

“如果在药品运输中没有实施持续的温度监控，则必须对运输路线进行风险评估。评估特别要包括运输时间，包括路线的特殊问题，季节和天数，包括天气预报，所用的货车及其装备。该风险评估的结果必须成为运输计划的一部分。”  赞同

毒手药王邓智先

学习一下

hongwei2000

对于一下GSP附录
就可以看到什么是教条主义了

lumang

谢谢分享，所有都要有数据支持！偏差处理也不例外。

xqliu

学习一下啦，谢谢提供分享。用法规及数据支持一切行动都是可控的。

一沙一叶

放两个温度记录仪也不费什么，万一中间有意外事件偏差也有数据支持啊

cph2345

运输过程如果不放温度监控装置，连个数据都没有，出现异常情况如何评估？冷链产品的运输过程中不可预测的异常情况太多了，总有你在验证的时候想不到的事情出现。比如你如果是长途运输，车辆在不同的地方抛锚可能造成的情况都有可能不一样的。冷链验证不可能模拟到所有可能的情况。为了保证产品质量还是放个温度记录装置吧。否则，只能评估产品报废了。

liwenxian

谢谢分享，学习了

Shurl

请问一下，欧盟有没有规定运输验证的周期是多少？

meiyududu

谢谢分享。。。

胖胖的水牛

谢谢分享！目前我们公司在对药品冷链运输时，冷藏车有温度监测系统，同时随货箱内还放有小型温度记录仪。因有时连续要在不同地方卸货，开门时车载温度系统数据会有1度左右上扬，随货数据一直良好，但就是有的客户不接收，要求车内温度系统与随货记录仪都在范围内才行，也不接受MKT计算，好头痛！全程增加了运输成本，客户又不干了！
个个都是，我物品少，可是我要求高呀！你必须便宜，因为我想得美呀！