Eudralex Volume 3 Guideline on Manufacture of the Finished Dosage Form
Titel:
Eudralex Volume 3 Guideline on Manufacture of the Finished Dosage Form
Internet:
Herkunft/Verlag:
EMA
Dokumentenart:
Guideline
Inhalt:
The note for guidance(CPMP/QWP/486/95)has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline are also taken into account.