Qualification of Impurities in Drug Substances and Drug Products

Raphy Nudelman, Teva Pharmaceutical Industries, Kfar Saba, Israel

Impurities are present in drug substance and drug products and they are unavoidable. Their properties and sources vary and accordingly their qualification is performed in accordance with regulatory guidelines and acceptable recommendations. This presentation will provide an overview of the different types of impurities found in drugs and the methods used in the industry to justify and qualify the levels they are found to be present in the drug substances and drug products.