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…
Revision of the CDMh’s Q&As document on nitrosamine impurities by Giuliana Miglierini The review process of medicinal products started in 2018 to assess the presence of nitrosamine…