15/16 February 2024
The publication of the revised draft of the EU GMP Guide's Annex 15 has attracted great attention in the industry. Uncertainty is partly high and change requests have been expressed. This can be seen in a survey carried out by the ECA Academy. That's why the results of the survey have also been sent to the EMA as comments.
Also the Austrian (aqpa) has commented the Annex 15 Draft. You can find the comments on the draft on the aqpa website.