4 September 2008
European Qualified Person (QP) Association passes 1000
Members Mark
As the European Qualified person (QP) Association announced, the
organisation crossed the 1000 members mark in August - only two years
after its foundation.
In July 2006 the European Compliance Academy's (ECA) Advisory Board
decided in its annual meeting to establish this new not for profit
organisation to provide QPs in Europe with the support needed in this
important quality management function and with a common strong voice. It
also provides a platform for networking, allowing QPs to exchange
experiences, discuss the latest regulatory requirements, to identify and
address difficulties and challenges and to support a harmonised European
approach.
The rapidly increasing number of members from across Europe and even
beyond emphasised this new organisation's high significance. Today, the
more than 1000 members, associate members and guests from close to 40
countries impressively prove this vital importance. Also, the annual QP
Forum the Association conducted only for the 2nd time last fall in
Berlin, Germany, was already attended by more than 200 delegates from
almost 30 countries. "Due to this great interest in our organisation, we
decided to keep membership free of charge", said Dr Bernd Renger,
Chairman of the European QP Association and Director Quality Control at
Vetter Pharma Fertigung in Germany. "We will also add further benefits
like higher rebates for events, making membership even more attractive",
he added.
In addition to the increasing attention from industry the European QP
Association also experiences more and more awareness from national and
international regulatory authorities. In fall 2007 the European QP
Association was invited to attend an EMEA Interest Group meeting, which
allowed Richard Bonner and Dr Renger to represent the voice of QPs in
Europe for the first time at this significant event.
Additionally to Dr Bernd Renger as chairman, the Association is led by
four colleagues from the ECA Advisory Board and an additional industry
professional: Martine Tratsaert, Belgium, Richard Bonner, and Dr
Christopher Burgess, both UK, and John Taylor from the Medicines and
Healthcare Products Regulatory Agency (MHRA), UK, as well as Rudolf
Völler from the GMP Inspectorate in Darmstadt, Germany.
Background
A Qualified Person's (QP) main responsibility task in pharmaceuticals
production is to ensure that each batch of a medicinal product has been
produced and tested in accordance with the EU Directives, Good
Manufacturing Practices (GMP) and the provision of the Marketing
Authorisation. Only with his certification and confirmation medicinal
products can be released for sale. The legal basis for Qualified Persons
in Europe clearly demonstrates this position's significance.
The QP's importance is evident through Article 48 of the EU Directive
2001/83/EC - stating that "EU Member States have to assure that each
holder of a manufacturing authorization have to have at his disposal at
least one QP" (Article 52 of Directive 2001/82 for veterinary medicinal
products respectively).
Article 49 (Article 53 of Directive 2001/82 for veterinary medicinal
products respectively) of the EU Directive strictly determines a QP's
qualification and experience level - basically a study in pharmacy or a
natural science with additional training and completed by acquired
practical experience over at least two years
The QP's legal responsibilities mentioned above are specified in Article
51 (Article 55 of Directive 2001/82 for veterinary medicinal products
respectively).
Although the EU Directive clearly determines qualification, experience
and responsibilities of QPs and this Directive is mandatory for EU
member states and has thus to be transferred into national law, the
subsequent national regulations are quite diverse and far from a
harmonised approach.
Therefore it is one of the main objectives of the European Qualified
person Association to advocate and support a harmonised approach for a
definition of the QP's role in the European Union.
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