Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

ICH Q3D and related impurities in antibiotics – new requirements for Active Substances in Europe ***

Lennart Seidler (Abschlußjahr: 2014)

Summary
Language: English
The control of impurities in Active Pharmaceutical Ingredients is currently undergoing far reaching changes. Europe will be faced with substantial changes in the control of elemental and genotoxic impurities due to the upcoming implementation of the ICH guidelines Q3D and M7. For the other ICH regions this will even set up completely new requirements, as specific guidance documents for these impurities have not been established or implemented earlier. In this publication, the change in requirements for the control of metal and elemental impurities is presented. As mentioned above, ICH initiated a similar change with regard to genotoxic impurities like for elemental impurities. The respective ICH guideline on genotoxic impurities was already sufficiently discussed recently (Osterhage, 2013) and is therefore not further covered in the following text. On a long term, the named ICH guidelines will replace existing guidelines of the European Medicines Agency (EMA) dealing with the same topics. The EMA itself has been active on another field where years ago, during the elaboration of the fundamental ICH guideline Q3A no consensus could be reached. In June 2013, a guideline dealing with related substances in antibiotics has been implemented. Substances of this important class of APIs were previously not covered by any regulation if they have been produced by fermentation or by fermentation and a following chemical modification. The new guideline closes therefore a significant gap in the regulatory framework for control of impurities.
Pages: 52, Annexes: 0