In September 2019 EMA published documents which request Marketing Authorisation Holders (MAHs) to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs. In case of contamination with Nitrosamines which requires critical changes in the manufacture of drug substances and drug products MAHs have to file a variation application. All regulatory activities with regard to such cases have to be completed within a 3 years period (end of March 2022). Contamination with Elemental Impurities (EIs) in drug products is a critical case as well. The ICH Q3D Guideline outlines PDE values for EIs and requests controls designed to limit their presence in Drug Products to levels at or below the PDE. As both Nitrosamines and EIs are of particular concern in pharmaceutical products European Pharmacopoeia policies had to be amended which led to the revision of a number of monographs.
The webinar addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered. This event will also address regulatory requirements and hence is applicable to people working in the regulatory affairs area.
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In this webinar you will get an update of European Pharmacopoeia activities around mutagenic impurities with focus on Nitrosamines and Elemental Impurities. You will be informed about
- how the control of Nitrosamines is reflected in the Ph. Eur.
- the changes in the individual and general monographs of the Ph. Eur.
- what has to be considered regarding the new general chapter on control of nitrosamines
- how ICH Q3D has been implemented in the Ph. Eur.
- the second phase for revision of excipient monographs
A representative of EDQM will explain the recent initiatives with respect to drug substance monographs of the Ph. Eur.