27/28 October 2021
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:
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:
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".