Impurity control is an essential aspect of quality control in individual monographs of the Ph. Eur. In this module, you will learn about the Ph. Eur. policy for impurity control. It covers all types of impurities, whether organic, inorganic (including elemental impurities), solvents or DNA-reactive impurities such as N-nitrosamines.
You will also learn about the analytical procedures used, the process of specification setting, the correct use of reference standards and how the different texts of the Ph. Eur. complement each other. In this context, the implementation of the relevant ICH guidelines and their importance for the Ph. Eur. are also discussed. The recording includes a Q&A session.
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Target audience
The module is of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.
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Duration: 1 hour, 33 minutes
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