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 the Good Practice Guide “Code of Practice for QPs”. 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 new version 9.0 launched in January 2023 now also comprises a new chapter “Ethics for the Qualified Person – A Professional Code of Conduct” in addition to general revisions and a revised Annex 1 with the national requirements.
Version 9.0, January 2023: EQPA Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU