EMA’s 3-year work plan for the Quality domain
by Giuliana Miglierini The European Medicines Agency has released the input notes made by the GMDP Inspectors Working…
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…
PIC/S Annual Report 2021
by Giuliana Miglierini The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and…
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16
by Giuliana Miglierini The entry into force of EU Regulation 536/2014 “Clinical trials”, at the end of January,…