(Treffer aus pharmind, Nr. 05, Seite 670 (2016))
Elemental Impurities: ICH Q3D finalized / New Implications for Manufacturers of Drug Products, APIs and Excipients · Reichert U · Merck KGaA, Darmstadt
The ICH Q3D guideline [ 1 ] introduces a risk assessment approach and limits for maximum permitted daily exposure (PDE) to control elemental impurities. The established PDEs are based on safety assessment for a chronic exposure and are considered to be protective of public health for all patient populations. This accounts not only for metals that have been added intentionally but also takes all possible forms of contamination of the drug product into consideration. The new guidance on elemental impurities closes a gap for the control of inorganic impurities. Until now the implemented ICH guidelines were primarily aimed to control ...