ICH Q7 How to do – Hot Topics from the revised APIC guidance

ICH Q7 How to do – Hot Topics from the revised APIC guidance

Budapest, Hungary

Seminar Nr. 16450


Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Hélène Bruguera, EDQM, France
Marieke van Dalen, Aspen Oss, The Netherlands
Mechthild Sander, Alfred E. Tiefenbacher, Germany


In this pre-Conference Session you get to know how the requirements of the ICH Q3D Guideline on Elemental Impurities affect the CEP procedure. You will learn

  • How to deal with these requirements when applying for a new CEP or a revision of an existing CEP
  • What EDQM expects with respect to elemental impurities when you submit a CEP application
  • Which consequences will arise from the comprehensive revision of pharmacopoeial monographs

Furthermore you get examples on how to perform a risk management summary for a CEP application.

This pre-conference session ideally complements the following 20th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients.


In August 2016, the EDQM released a policy document entitled “Implementation of ICH Q3D in the Certification Procedure” (PA/PH/CEP(16)23). The document describes which data on elemental impurities are required for a new CEP application and for the revision/renewal of an existing CEP. An important part of the document is an Annex 1 providing an example of a risk management summary (RMS). Another important document was published in March 2017 by EMA entitled „Implementation strategy of ICH Q3D guideline“ (EMA/CHMP/QWP/115498/2017). This document addresses specific considerations to enable the practical implementation of ICH Q3D in the EU by providing guidance for Appplicants/MAHs. It applies to new applications, as well as variations to existing authorised medicinal products and also reflects dossier expectations and assessment strategy regarding CEPs and ASMFs.


This pre-Conference Session is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations in the EU especially the documentation of the drug substance quality in a CEP. Furthermore the Session will be of interest to personnel from Regulatory Affairs, Quality Assurance, Quality Control, Production and Project Management of the pharmaceutical and the API industry.


Elemental Impurities and CEPs – Requirements for new CEP applications, already existing CEPs and CEP revisions

This pre-Conference Session ideally complements the subsequent 20th APIC/CEFIC Conference on Active Pharmaceutical Ingredients.
If you register both for the pre-Conference Session „Elemental Impurities and CEPs – Requirements for new CEP applications, already existing CEPs and CEP revisions“ and the 20th APIC/CEFIC Conference you will benefit from a special rate of 690 EUR (instead of 890 EUR) for the pre-Conference Session!


The ICH Q3D Guideline – an overview

  • Which elements are covered in the guideline
  • What is expected from Marketing Authorization Holders
  • How to prepare the risk assessment
ICH Q3D and the European Pharmacopoeia
  • General chapters on elemental impurities
  • Impact of ICh Q3D on individual monographs
  • Removal of the test 2.4.8 for heavy metals
EDQM’s implementation policy of ICH Q3D in the Certification Procedure
  • How to implement the principles of ICH Q3D at the level of substances
  • Content of the CEP dossier with regards elemental impurities
  • Impact on new and granted CEPs
ICH Q3D and the global Pharmacopoeial consequences
  • Deletion of the heavy metals test for API‘s
  • Consequences for global registration
Elemental impurities risk assessment of Drug Products

Risk evaluation of elemental impurities in Drug Substances – EDQM’s perspective
  • Addressing the relevant elemental impurities
  • Control strategy for drug substances manufacturers
Elemental impurities risk evaluation of Drug Substances – API manufacturer’s perspective


GMP Seminare nach Thema

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