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QP Association - Publications

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Good Practice Guide No 2: Duties and Responsibilities for Qualified Persons in the EU

On 22 November 2007, Version 1.0 of the Good Practice Guide No 2: "Duties and Responsibilities for Qualified Persons in the EU" was released. It is the aim of this document to support the Qualified Persons in Europe with an overview about the legal basis in Europe as well as in the different EU Member States.

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 here. However, a number of responsibilities as well as requirements for continuous training for QPs are not defined in detail. This Good Practice Guide considered a "living document" gives recommendations to QPs.

The Good Practice Guide can be downloaded for free by members of the European QP Association in the Members Area.