Impurities Forum - Part III / Genotoxic Impurities

Impurities Forum - Part III / Genotoxic Impurities

Prague, Czech Republic

Course No 9260


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Speaker from Authority
DR CORINA NACHTSHEIM, Quality Assessor, Germany

Industry Speakers
DR GISELA FONTAINE, Solvias AG, Switzerland
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
DR HEIKE SCHMIDT-EISENLOHR, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR XAVER SCHRATT, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR LANCE SMALLSHAW, UCB Biopharma sprl, Belgium
DR ANDREW TEASDALE, Astrazeneca, United Kingdom
DR ANDREAS WOLF, AbbVie, Germany


Part III of the Impurities Forum will cover the key aspects of determining, analysing and assessing genotoxic impurities.

You will learn
What authorities expect and how they assess genotoxic impurities
How TTC levels of genotoxic impurities can be determined for different dosage forms
Which methodologies can be applied to predict potential genotoxic impurities
The key aspects to be considered when dealing with mutagenic impurities
How to implement the requirements of ICH M7 from a quality and safety perspective


Potential genotoxic impurities may arise from several sources. They may be generated as by-products in chemical synthesis or as degradants during storage. Therefore the determination of such impurities, their toxicological assessment and the establishment of acceptable limits is absolutely essential with respect to patient safety. Special guidance in terms of quality and safety risk management and assessment is provided by the EMA “Guideline on the Limits of Genotoxic Impurities” and the ICH M7 Draft Consensus Guideline on “Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk”.

Target Group

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.


Part III: Genotoxic Impurities
Genotoxic Impurities – requirements and authorities expectations
General documents and Guidelines for the assessment of genotoxic 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”

Case studies for the assessment of potential genotoxic impurities
Examples of low daily dose drug substances
Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
Potential genotoxic residual solvents
Impurities derived from metal catalysts

ICH M7 Guideline – Mutagenic Impurities: overview of key aspects
Applicability of the M7 Guideline
General principles
Considerations for marketed products

ICH M7 Guideline – practical implementation: a quality perspective
Drug substance and drug product impurity assessment
Hazard assessment elements
Computational toxicology assessment
Structure activity relationships
Process related impurities
Control strategy approaches

ICH M7 Guideline – practical implementation: a safety perspective
Lifecycle management
Considerations for clinical development
In vivo relevance of in vitro mutagens
Linear extrapolation from TD50; calculation examples

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