10 May 2023
EQPA revises Good Practice Guide
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.
Version 10.0 has now been published. Besides general linguistic changes and a structural review for clarity, the following amendments were made:
- new elaborated chapter on Brexit and consequences
- revision of chapter on clinical trials, adoption to Clinical trial Regulation
- update on all references to the Clinical Trial Regulation, Veterinary Medicines Regulation and ATMP Regulation/GMP Part IV
- integration of Annex 21 for importation
- integration of EQPA survey results as appropriate
The Good Practice Guide including a chapter on the “Ethics for the Qualified Person – A Professional Code of Conduct” and 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.
If you are member please use the login at the top to get to the Good Practice Guide. If you would like to apply for membership, please
see the membership application forms.
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