Impurities Forum 2019 Part II - Elemental and Genotoxic Impurities
Im Auftrag der ECA Academy

Impurities Forum 2019 Part II - Elemental and Genotoxic Impurities Im Auftrag der ECA Academy

Praha, Czech Republic

Seminar Nr. 16957


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Dr Gisela Fontaine, Solvias AG, Switzerland
Dr Corina Nachtsheim, Quality Assessor, Germany
Dr Andrew Teasdale, AstraZeneca, United Kingdom


In Part II of the Impurities Forum the key principles of the 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,
  • how to develop suitable analytical methods for genotoxic impurities determination,
  • regulatory filing: what do regulatory authorities expect?
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
Meanwhile ICH Q3D was revised twice, regarding Cadmium Inhalation PDE (ICH Q3D(R1); Step 2 document) and cutaneous and transdermal products (ICH Q3D(R2); Concept Paper).

Equally the ICH M7 Guideline for Assessment and Control of DNA reactive (mutagenic) impurities has undergone a twofold revision: ICH M7(R1) (Step 4 document) being completed by an Addendum containing a summary of known mutagenic impurities commonly found or used in drug synthesis and ICH M7(R2) (Concept Paper) where PDEs for new DNA reactive (mutagenic) impurities have been incorporated.


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.


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
Analytical methods to determine elemental 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)
Mutagenic Impurities: how to develop suitable analytical methods for detection
  • Challenges associated with MI analytical method development
  • Class based methods vs individually designed messages
  • Technologies
  • GC-vs LC
  • Chromatography vs NMR
  • Validation requirements
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.

Mutagenic Impurities – requirements, authorities expectations and case studies
  • General documents and Guidelines for the assessment of mutagenic impurities
  • The assessor’s approach: principles of toxicological assessment
  • The TTC concept
  • Structural alerts
  • Limits and Permitted Daily Exposure
  • The ALARP principle
  • Applicability of the EU “Guideline on the Limits of Genotoxic Impurities”
  • Examples of low daily dose drug substances
  • Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
  • Nitrosamines – the Valsartan case
  • Potential mutagenicc residual solvents
  • Impurities derived from metal catalysts


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