5PSQ-112 Risk assessment of elemental impurties for manufacturing the drug substance (ICH Q3D)

BackgroundThe new ICH Q3D guideline has been recently developed to define and provide a global policy for evaluating and limiting elemental impurities in drug products. Thus, a risk assessment and appropriate control of elemental impurities according to this guideline have become necessary.PurposeTh...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	European journal of hospital pharmacy. Science and practice 2019-03, Vol.26 (Suppl 1), p.A253-A254
Hauptverfasser:	Bennis, S, Yachi, L, Ouhaddouch, H, Alami Chentoufi, M, Cheikh, A, Bouatia, M
Format:	Artikel
Sprache:	eng
Schlagworte:	Risk assessment
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!