The first revision of the ERA guideline on environmental risk assessment
by Giuliana Miglierini It took eight years before revision 1 of the EMA guideline on environmental risk assessment…
The first Union list of critical medicines
by Giuliana Miglierini The first version of the Union list of critical medicines was published on 12 December…
PIC/S new guidance documents for GDP inspectors
By Giuliana Miglierini Two new guidance documents for GDP inspectors have been issued by the Pharmaceutical Inspection Cooperation…
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…
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…
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…