Authority uses Margin of Interpretation regarding Qualification as QP

Recommendation

7/8 September 2022
Vienna, Austria

Quality Culture
People Empowerment in GMP

The Danish Health and Medicines Authority (DHMA) has published a document which shows that the EU has left enough leeway for the implementation of EU directives. This could be an option in other EU Member States to prevent the threatening shortage of QPs (Qualified Persons). 

EU Directive 2001/83, Article 49 provides a list of the academic requirements. This subject catalogue is more or less equivalent to a degree in pharmacy. The document of the DHMA presents a possible exception to that. It says: "However, the requirement that a QP must have received training in all of the above-mentioned basic subjects can be waived. The specific subjects required will depend on the medicinal products which the applicant will be releasing." Similar regulations exist in other Member States. In Germany for example, exceptions are described in §15 of the German Drug Law for blood preparations, serum vaccines, allergens, test sera, test antigens, advanced therapies, xenogeneic medicinal products, tissue preparations, medicinal products for  in-vivo diagnostic using marker genes, radiopharmaceuticals and APIs. However in the same paragraph, the German law states that "a minimum of two years practical experience in the areas of qualitative and quantitative analytics is required" to qualify as QP. In a few words, it strictly adheres here to the EU regulation.

Now, the Danish authority shows in their document that things can be different. Indeed, practical experience in production and quality assurance are recognisable ("Experience from production, QA or QC") unlike in other EU countries and Germany. This offers career perspectives for many who could be good QPs.

Source: Guidelines on requirements and expectations for the qualified person in a pharmaceutical company