The ICH Q3D guideline represented a change of paradigm in the control of elemental impurities in medicinal products. In Europe, the guideline is applicable for new or existing marketing authorisations since June 2016 and for authorised medicinal products since December 2017. It is legally binding in the 39 member States of the European Pharmacopoeia since January 2018.
This webinar is intended as a refresher for users, explaining the implementation of ICH Q3D in the texts of the European Pharmacopoeia and the control of elemental impurities in medicinal products using the principles of risk management.
The presentation consists of two parts and covers the following topics:
Part 1: European Pharmacopoeia
- Implementation of Q3D in the European Pharmacopoeia
- Highlight changes in general and individual monographs
- Harmonisation of general chapter 2.4.20
- The revision of excipient monographs (Phase two)
Part 2: CEP Procedure
- Impact of the Implementation of ICH Q3D in the European Pharmacopoeia
- CEP policy on elemental impurities and examples
Duration: 1 hour, 15 minutes
This webinar is of interest to professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs.
Download the presentations
- European Pharmacopoeia Activities on Elemental Impurities by Ulrich Rose and Amela Saračević
- Implementation of Q3D and the Certification Procedure by Pascale Poukens-Renwart
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