19 November 2010
Will there soon be a shortage of QPs?
The
requirement profile for Qualified Persons (QP) is defined in the
European Directive 2001/83/EU. In the various EU member countries this
guideline’s content is not implemented the same way, though. Many
countries require a broad academic education which ultimately equals the
studies of pharmaceutics. Graduates from other (natural science) studies
can theoretically become QP in the area of medicinal products as well –
if they cover subjects at an appropriate university they did not cover
during studies before. This is currently a huge problem because a lot of
member states do not offer an adequate academic training by standard (as
e.g. in Germany), and those that were passed, are more or less the
result of hard work from private initiatives.
Another
obstacle for the recognition as QP is the required fulfilment of two
years practical experience which needs to be gained in the qualitative
and quantitative analysis of medicinal products in with a company
holding a marketing authorisation. This excludes many graduates who can
not provide the necessary proof from their university, but also
pharmacists who gained their practical experience rather in the
manufacture of medicinal products than in the analysis. In both areas
there are professionals, though, who would be absolutely eligible to
assume a QP function.
The European QP Association (EQPA), the interest group of European QPs,
has been already criticising this situation as well as the different
interpretation of the Directive in the various Member States. Moreover,
the German “Verband der forschenden Pharma-Unternehmen (VfA)” which is
the German association of researching medicinal product manufacturers,
just issued an according position paper. In the association’s view it
is urgently necessary to review the existing regulations regarding the
required proof of expertise for QPs to avoid that there is an increasingly
smaller group of professionals who can assume QP functions. In this context
the VfA requests a much more pragmatic interpretation of the requirements
with regard to expertise and experience. The association also recommends
to also acknowledge courses completed outside academic pharmaceutical studies.
The European QP Association (EQPA) welcomes the VfA’s position paper and will
fully support further planned activities of the association.
Dr Bernd Renger
Chairman of the European QP Association
http://www.vfa.de/download/qualified-person.pdf
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