Elemental impurities According to ICH Q3D
25th January 2016
Elemental impurities according to ICH Q3D: APIs & excipient suppliers as potential sources...
Elemental impurities according to ICH Q3D: APIs & excipient suppliers as potential sources
ICH Q3D Step4 will have to be applied very soon: June 2016 for new Drug Products and 1st January 2018 for all existing DP, making it mandatory for all manufacturers to carry out a risk assessment to control elemental impurities in their DP.
Such evaluation needs to consider all potential sources of Elemental Impurities and obviously, drug product components are probably the most likely contributors...
Watch the conference given by Philippe De Raeve, Scientific Director at Quality Assistance
(CPhI Madrid - 15.10.2015)