null Approaches for CEPs and the Ph. Eur. strategy with regard to nitrosamine control: current guidance and practical implementation

EUROPEAN PHARMACOPOEIA 22/04/2021 PDF Presentation

Since the discovery of nitrosamines in sartan medicines, the EDQM and the European Pharmacopoeia (Ph. Eur.) Commission have taken action to address their presence in active pharmaceutical ingredients (APIs). In this webinar, the EDQM provides users and stakeholders with an update and detailed overview of the approaches for CEPs and the Ph. Eur. strategy with regard to controlling these impurities. There is a presentation on the recently revised Ph. Eur. monographs for the five sartans with a tetrazole ring, explaining the changes made with a view to helping users in appropriately applying the texts.

With regard to substances covered by CEPs, applicants and CEP holders are requested to include a risk assessment in any new CEP application, sister file or renewal application, as well as in any revision where there is a risk of nitrosamine formation. Furthermore, manufacturers are required to demonstrate that appropriate controls have been established to ensure that these impurities are not present in their active substances.

The speakers share the EDQM’s expectations with regard to carrying out a risk assessment and identifying appropriate control strategies, as well as the data that should be provided in CEP applications to meet the requirements.

Topics include:

  • Nitrosamine control in the Ph. Eur.: special focus on recently revised monographs for sartans with a tetrazole ring
  • Expectations for the implementation of risk assessment and control strategies for nitrosamines in substances covered by CEPs
  • Implementation of revised Ph. Eur. monographs for CEPs for sartan active substance

Target audience

This webinar 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 also be of interest to CEP holders and users of CEPs, including competent authorities.

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