Welcome to the European QP Association

Each holder of a manufacturing authorisation for medicinal products in Europe needs to name at least one Qualified Person (QP). A Qualified Person's function and responsibility is therefore unique.

The legal basis for the appointment of a QP is defined in the DIRECTIVE 2001/83/ relating to human medicinal products including Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) and in REGULATION 2019/6 relating to veterinary medicinal products. Both the directive and the regulation clearly determine a professional’s educational background and professional experience needed to act as a QP as well as the duties and responsibilities associated with this function. This European approach means that the QP is not only required 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 Advisory Board Members of the ECA Foundation decided at their annual meeting on 7 July 2006 to establish the European QP Association. With this association the ECA wants to represent QPs in the European Union, the United Kingdom, Switzerland, and beyond  and to support them e.g.

• by providing a platform for the exchange of experience,
• by providing training and conferences,
• by discussing the latest regulatory requirements,
• by addressing difficulties and challenges and
• by supporting a harmonised European approach.

Here you find shortkeys to some of the website's information.