Comments to the draft ICH guidelines Q2(R2) and ICH Q14
by Giuliana Miglierini The public consultation on the two draft guidelines ICH Q2(R2) on the validation of analytical…
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)…
Automation of aseptic manufacturing
by Giliana Miglierini The pharmaceutical industry is often the last industrial sector to implement many new manufacturing and…