20150326 ECA新闻：GDP培训：需要多少？

20150326 ECA新闻：GDP培训：需要多少？  

2015-03-26 22:34:32|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015226103432309/

GMP News
26/03/2015

Good Distribution Practice (GDP) Training: How much is needed?

GDP培训：需要多少？

  Since the EU Good Distribution Practice (GDP) Guide has been revised in March 2013 (an additional minor revision took place in November 2013) there is a lot of discussion about the interpretation of certain requirements. Among others, the training of personnel is a topic which received attention.

自从2013年3月GDP指南修订后（在2013年11月又进行了一些小的修订），对于某些要求有很多讨论。其中，人员培训是受到很大关注的话题。

The GDP Guide states in Chapter 2 (2.4): "All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Personnel should receive initial and continuing training relevant to their role,based on written procedures and in accordance with a written training programme."

GDP指南的第2章2.4节里说“所有参与批发分销活动的人员均应培训GDP的要求。他们在承担其任务前应具备适当的资质和经验。人员应接受与其工作相关的上岗前初始培训及持续培训，这些培训应基于书面培训，并符合书面培训计划。”

Although it looks as the text is very general there are some important details which provide information. Those details are highlighted in the above text.

尽管这些文字看起来非常泛泛，但这里有一些重要细节提供了相关的信息。这些细节在上述文字中以粗体显示。

1) It is important to say that all personnel - and not only key personnel - need to receive GDP training if they are involved in distribution activities. This will also mean that for example also the truck driver and employees in the warehouse who handle medicinal products need GDP training. Companies are free to decide which training methods they use. In-house GDP Training Courses or GDP eLearning might be an option.

需要说明的很重要的一点是所有人员----不仅是关键人员----如果他们参与分销活动的话，需要接受GDP培训。这也就是说，例如，卡车司机和仓库里搬运药品的员工都要接受GDP培训。公司可以自由决定采用何种培训方法。内部GDP培训课程或电子学习都是可以的。

2) The training has to be performed "prior to commencing their tasks". This means that before a new employee can start any activities related to medicinal products training has to be performed. Inspectors might want to see the training records to check if the training was performed when the employee joined the company.

培训必须“在承担其任务前”进行。这就是说在一个新员工开始参与药品相关的活动前，必须接受培训。检查员可能会想看一下培训记录，以检查是否员工在进入公司时就接受了培训。

3) Initial and continuing training is required. Therefore there is not excuse to say that certain employees have already performed a certain task for years. Also here training records should state that ongoing training was performed

需要进行初始和后续培训。所以没有借口说特定的员工已从事了某项任务很多年而不需要培训。这里培训记录还应说明实施了后续培训。

4) A training programme and a SOP which defines how the training programme will be managed is a key requirement. A comprehensive training programme for all employees in the GDP environment is a challenging task. A monitoring system is needed to identify when new or follow up training is needed.

一个培训计划和一个SOP用以定义如何管理一个培训计划是一个关键的要求。一份针对所有GMP环境下的员工的综合培训计划是一个挑战性的任务。需要有一个监控体系来识别什么 时候需要新的或跟踪培训。

Often discussions come up because of the word "should". However, the interpretation is clear. Every "should" in the GDP Guideline can only be understood as "must".

经常会有关于单词“should的讨论”，在这里，解释是很清楚的。在GDP指南里所有的单词“should”都只能理解为“必须”。

Chapter 2.4 also defines that certain tasks need special attention. Therefore employees need specific training if they are involved in those tasks. As examples the GDP Guide lists: hazardous products, radio active materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products. Moreover, the training "should include aspects of product identification and avoidance of falsified medicines entering the supply chain". This is certainly a requirement very few companies have already established.

第2.4节也定义了需要特别注意的任务。因此，如果员工参与这些任务的话，则需要进行特定的培训。GDP指南中给出了一些例子：有害药品、辐射性活性物料、有滥用风险的药品（包括麻醉品和精神类物质）、温度敏感性药品。另外，培训“应包括药品的识别知识，避免假药进入供应链”。肯定只有很少的公司已经建立了这样的程序来符合这项要求。

Finally there is a requirement in Chapter 2.4 that training records should be kept and the effectiveness of training should be periodically assessed and documented. There is no statement about how the effectiveness can be checked. A documented exam/test is an obvious way to check the effectiveness, but there are also other options possible. In any case the effectiveness needs to be measured.

最后，在2.4节有一个要求，就是培训记录应保存，培训有效性应定期进行评估和记录。这里并没有说明有效性如何检查。显然一份记录的测试/考试是检查有效性的方法，但也可以有其它一些可选方式。不管怎样，培训的有效性都需要进行考量。

群里信息很及时，很快就有对应的中文了。赞！