Les Impuretés Élémentaires De Synthèse En Pharmacie

Abstract

Our work focuse on the different elemental impurities in the pharmaceutical industry according to new regulatory requirements, including which Quality has taken on considerable importance in medical and pharmaceutical practice. The objective of this thesis is to assess the role of regulatory bodies and new methods to properly detect these impurities, to value it and to estimate its impact in pharmacovigilance as an example. During the first part of this work, we were interested in studying the various impurities which may be present in the pharmaceutical product, in particular the elemental impurities and the risks which may be generated. In the second part, the study of the context, of the current regulatory and normative requirements which will allow us to understand such an evolution; and lead us to present for you the application of this regulation at the level of the pharmaceutical industry in a third part, a fourth part which is interested in the control of these elementary impurities as well as the analytical methods, finally our work ends with a case study of a paracetamol molecule.