The Impurities Workshop - Part II: Eelemental Impurities and update on Mutagenic Impurities
Im Auftrag der ECA Academy

The Impurities Workshop - Part II: Eelemental Impurities and update on Mutagenic Impurities Im Auftrag der ECA Academy

Copenhagen, Denmark

Seminar Nr. 16408


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Speaker from Authority
DR ULRICH ROSE, Strasbourg, France

Industry Speakers
DR CHRISTOPHER DAY, AstraZeneca, United Kingdom
DR MANFRED FISCHER, Skyepharma (member of Vectura group), Muttenz, Switzerland
DR CRINA HEGHES, Lhasa Limited, United Kingdom
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
GRACE KOCKS, Lhasa Limited, United Kingdom
DR ANDREW TEASDALE, AstraZeneca, United Kingdom
DR LISE VANDERKELEN, Nelson Labs, Belgium


In Part II of the Impurities Forum the key principles of the new ICH Q3D Guideline will be highlighted. You will get to know the essential aspects and approaches of determining and controlling elemental impurities in drug products. You will learn

  • which are the principles of the elemental impurities risk assessment process,
  • factors that affect the limits – route of administration and also duration of exposure,
  • how to implement risk-based strategies to control elemental impurities,
  • which analytical methods are suitable to determine,
  • elemental impurities and what you have to consider when you apply them,
  • what you need in your QC lab to be prepared for elemental impurities analytics.

Moreover you will hear about recent developments regarding the control of Mutagenic Impurities according to ICH M7.


In November 2014, the ICH Q3D Guideline for Elemental Impurities was published as Step 4 document. This document outlines

  • the evaluation of the toxicity data for potential elemental impurities,
  • the PDEs for each element of toxicological concern,
  • the basis for an EI risk assessment and the key factors for evaluation,
  • the development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE.

In March 2015 USP announced a revision to General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements, establishing 1 January 2018 as the new date of applicability of General Chapters <232> Elemental Impurities-Limits and <2232> Elemental Contaminants in Dietary Supplements. In November 2015 the European Pharmacopoeia adopted the deletion of the test for heavy metals (2.4.8) from approx. 760 individual monographs on substances for pharmaceutical use (except substances for veterinary use only).


The conference 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.


Implementation of ICH Q3D in the European Pharmacopoeia

  • History of heavy metals tests
  • Implementation strategy of ICH Q3D in Ph. Eur.
  • Modifications of general chapters and general monographs
  • Specific metal tests in individual monographs
Analytical methods to determine metallic impurities
  • Principles and characteristics of the most common spectrometric techniques AAS, ICP-OES, ICP-MS
  • Compound methods (sample preparation plus spectrometric detection and quantification)
  • Special considerations for trace-elemental analysis
  • Application-based approach for choice of methodology
  • Analytical process (method development, validation strategy, routine testing)
Control Strategies for Elemental Impurities in final dosage forms – Case studies
  • Utilisation of Data as part of an Integrated EI Risk Assessment Process
  • Potential Sources of Elemental Impurities in the Finished Product: API, Equipment, Container-closure system, Excipients
  • Conclusions
Workshop: Conducting a risk assessment
In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.

Reflections on ICH M7 – Recent developments and their impact / implications:
  • In silico predictions – overview of tools available / reflections on expert data review
  • Control options - Use of Purge calculations within control strategy
  • Compound specific limits – the ICH M7 addendum and beyond
  • Analysis of MIs – Key points from recent review article


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