Consultation on the revision of the Guideline on the chemistry of active substances
by Giuliana Miglierini The public consultation on the draft Guideline on the chemistry of active substances is open…
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…
Consultation open on the ICH Q13 guideline on continuous manufacturing
by Giuliana Miglierini The new ICH Q13 guideline on the continuous manufacturing of drug substances and drug products…