Impurity control is an essential aspect of quality control in individual monographs of the Ph. Eur. In this module, you learn about the Ph. Eur. policy on impurity control. It covers all types of impurities, whether they are organic, inorganic (including elemental impurities), solvents or DNA-reactive impurities such as N-nitrosamines.
You also learn about analytical procedures used, specification setting, the correct use of reference standards and the link between individual and general monographs and general chapters and their mandatory or non-mandatory nature. 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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This module is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, for example, newly graduated or early-career professionals.
Duration: 1 hour, 30 minutes
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