GQPA has developed a position paper to help shape the req...

胜利者

The German Qualified Person Association (GQPA) has developed a position paper with own proposals to help shape the requirements on the qualification of Qualified Persons.

In a recently published position paper, the GQPA discusses the background and the possible inadequacies of basic and ongoing educational training of Qualified Persons (QP). Another topic discussed is the lack of unified recognition of QPs by the different competent authorities in Germany.

A specially founded working group of the GQPA has now elaborated a proposal and set it out in a position paper which has been sighted, supplemented, rectified and finally adopted by the members of the GQPA.

The main objectives are:

• Assuring medicinal products safety
• Determining a "minimum" basic qualification ("Essentials")
• Defining ongoing training and specialisation requirements ("Add-Ons")
• A QP job description
• Improving QP awareness
  

In its paper, the GQPA judges QP training as "heterogeneous, good structured in some companies but suboptimal in others". Moreover, the legal requirements in Germany do not cover experience in manufacturing as a pre-requisite to become a QP. Despite this, there is a lack of QPs in German facilities. According to the paper, there seems to be uncertainties with regard to the acceptance of monitoring authorities i.e. authorities seem to assess the suitability differently depending on the federal state.
Now, the GQPA is putting the following items up for discussion:
In accordance with § 15, 1 AMG (German Medicines Act), activities in the field of qualitative and quantitative analysis as well as other quality testing of medicinal products should be procured during a 2-year period. Moreover, knowledge on other topics should also be acquired, e.g. in the fields of:

• Microbiology
• QA systems and basic GMP understanding
• Manufacturing
• General legal aspects and facts
  

For the creators of the paper, characteristics like management skills, social competence, flexibility, decision-making ability and a high assertiveness are essential.

In the GQPA's opinion, advanced and in-depth knowledge are "of high importance" and "should thus be acquired  in the course of ongoing training (=Add-Ons); depending on the task field during the practical activity (see above) or afterwards".

胜利者

认识德语的看过来

刀劈大脑

这是中国人写的文章吗？

syhorchid

呵，一会儿英语，一会儿德语。这不是埋汰人嘛。

胜利者

syhorchid 发表于 2016-4-24 17:33
呵，一会儿英语，一会儿德语。这不是埋汰人嘛。

坛里不缺高人

胜利者

gxj19871212 发表于 2016-4-24 17:28
这是中国人写的文章吗？

从ECA的网上复制

一沙一叶

摘要相对容易看一下

kc1711422001

Thanks for sharing

globle001

多谢分享