IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17


Inside this issue


Free webinar on elemental impurities: implementation of ICH Q3D

The ICH Q3D guideline represents a change of paradigm in the control of elemental impurities in medicinal products. In Europe, the guideline has been applicable to new marketing authorisations since June 2016 and will also become mandatory for authorised medicinal products within its scope as of December 2017.

Bearing this in mind, the EDQM will repeat its webinar on 16 May to explain how the implementation of ICH Q3D impacts the following areas:

  • texts of the European Pharmacopoeia
  • the assessment of CEP applications, following the release of the EDQM policy document “Implementation of ICH Q3D in the Certification Procedure” (PA/PH/CEP (16) 23)

The presentation consists of two parts and will cover the following topics:

Part 1 (about 20 min)

  • Implementation of the ICH Q3D in the general monographs and chapters
  • Impact of the ICH Q3D on individual monographs on substances for pharmaceutical use

Part 2 (about 40 min)

  • Overview of the Certification policy: possible scenarios, expectations on content and assessment
  • Case studies
  • Impact of ICH Q3D and the Ph. Eur. policy on existing CEPs, treatment revisions and renewals
  • How to interpret and use the information relating to elemental impurities when mentioned on CEPs

The webinar will be presented by Bruno Spieldenner, Scientific Officer in the European Pharmacopoeia Department and Mr Lennart Seidler, Scientific Officer in the Certification of Substances Department.

More information is available here.




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