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…
The new Annex 21 to GMPs
by Giuliana Miglierini The new Annex 21 to GMPs (C(2022) 843 final) that EIPG gave a significant contribution…
The new PIC/S guideline on data integrity
by Giuliana Miglierini The long waited new PIC/S guideline PI 041-1 has been finally released on July 1st;…