ECA Foundation's EQPA changes Membership Requirements

According to the European regulations the Qualified Person (QP) not only needs to be highly qualified, but also to always have the latest information on current developments in the area of GMP/GDP and regulatory compliance. For this reason the ECA decided in 2006 to establish the European QP Association (EQPA) to support QPs in the European Union by providing them with a platform for exchanging experience, by discussing the latest regulatory requirements, by addressing difficulties and challenges and also to support a harmonised European approach. Today the European QP Association represents close to 4.000 Qualifed Persons from across Europe and similar functions from beyond.

To accomplish its goals, the QP Association has continuously developed its activities and expanded its services. The exclusive members' area provides access to 

  • the online discussion forum for exchanging information and experience as well as for discussing current issues and challenges.
  • a Good Practice Guide summarising information on the responsibilities and duties of QPs in Europe and showing the various national requirements for becoming a QP
  • the shared audits database "QPSHARE" supporting QPs in finding and contacting potential partners for sharing audits
  • a Tool Box for QPs providing a compilation of tools like checklists, decision trees and workflows that could be used for structuring batch release decisions that would ensure all relevant points have been considered.

Further, the annually organised QP Forum is today's principal meeting point for European QPs. In addition, the organisation also conducts education courses and conferences for trainee and newly qualified QPs and supports training courses organised by the ECA. Finally, results from surveys conducted among its members have become a recognized source of information for authorities, industry and other industry organisations.

Qualified Persons and professionals in similar functions can join the European QP Association free of charge. At its Board of Directors meeting in early December, the EQPA decided, though, to concretise its requirements for membership. This was due to ambiguities in the previous requirements, changes in the political landscape and planned adjustments in PIC/S countries. The changes apply to all new memberships, existing memberships are not affected.

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