This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants will receive information on the selection of sites by the EDQM, as well as indications on how to prepare efficiently for a GMP inspection, in particular with regard to obligations/communication ahead of time. An overview of the nature and distribution of GMP violations observed during EDQM inspections conducted in recent years will also be provided.
The presentations will be followed by a live Q&A session.
Programme (subject to change):
10:00-11:00 Introduction to the EDQM inspection programme
11:00-11:30 How to prepare for an inspection – Most common GMP deficiencies
11:30-12:00 Live Q&A session