Code of Practice for QPs

The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in a core document, developed and published by the EQPA Board: the “EQPA Code of Practice for QPs”. This Good Practice Guide reflects the consolidated view of the EQPA board and is recognized as a reference of an appropriate interpretation of the concept and role of the Qualified Person in EU. The EQPA is promoting this view in conferences, training courses and conferences as well as in comments to existing legislation. Further, a number of responsibilities as well as requirements for continuous training for QPs are not defined in detail. This Good Practice Guide - considered as a "living document" - gives recommendations to QPs.

The Guide also comprises a Code of Conduct. A code like this is required in Article 52 of EU Directive 2001/83/EC, but has not been published by any EU/EEA authority so far. For that reason the EQPA Board decided to incorporate this code entitled “Ethics for the Qualified Person – A Professional Code of Conduct” as chapter 3 – until an official version becomes available by the EU regulatory or National Competent Authorities (NCAs).

The code is specifically intended to define and ensure the ethical dimension for QPs. It might also be used in informing other groups (e.g. senior management) of the specific duties of the QPs. It is further intended to become a reference to QPs and NCAs.

The Good Practice Guide including the chapter on a Professional Code of Conduct and with the Annex on National QP Implementation is accessible exclusively for members of the European QP Association. To find out more about the Guide, please see the more detailed information and a video (please note: if you cannot see the video, please open the privacy settings and mark "Vimeo" in the Functional settings):.

If you are member please use the login at the top of this page to get to the Good Practice Guide. If you would like to apply for a free membership, please see the membership application forms.