EIPG Training Course: Annex 1
Dear colleagues, I am very pleased to announce the GMP/Annex 1 Professional Training Course which will be held…
A concept paper on the revision of Annex 11
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP)…
The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment
by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company…
Current inspection trends and new approaches to the monitoring of post-inspection activities
by Giuliana Miglierini The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its Annual Regulatory GMP/GDP…
EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…
FAT and SAT, a critical step for the introduction of new equipment
by Giuliana Miglierini There are two key moments to be faced to introduce a new piece of equipment…