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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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