Impurities Workshop - Part II: Mutagenic Impurities

15 June 2016, Heidelberg, Germany

Course No. 15496



DR CORINA NACHTSHEIM, Quality Assessor, Germany
DR GISELA FONTAINE, Solvias AG, Switzerland
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
DR SAMUEL POWELL, Pfizer, United Kingdom
DR ULRICH ROSE, Strasbourg, France
DR XAVER SCHRATT, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR ANDREW TEASDALE, AstraZeneca, United Kingdom


Part II of The Impurities Workshop will cover the key aspects of determining, analysing and assessing mutagenic impurities. You will learn
What authorities expect and how they assess mutagenic impurities
How TTC-levels of mutagenic impurities can be determined for different dosage forms
Which methodologies can be applied to predict potential mutagenic 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 mutagenic 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 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.


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
Potential mutagenicc residual solvents
Impurities derived from metal catalysts

ICH M7 Guideline – Mutagenic Impurities: overview of key aspects
Applicability of the M7 Guideline
General principles
Modified Limits based on patient population / unmet medical need
Considerations for marketed products

ICH M7 Guideline – practical implementation: a quality and safety perspective
Drug substance and drug product impurity assessment
Hazard assessment elements
Computational toxicology assessment
Structure activity relationships
Process related impurities
Control strategy approaches
Lifecycle management
Considerations for clinical development
In vivo relevance of in vitro mutagens
Linear extrapolation from TD50; calculation examples

Workshop: Compound-specific risk assessment for mutagenic impurities
In this Workshop participants will be shown the basis of how safety data can be effectively utilised to calculate compound specific limits. How the data can be interpreted, based on mechanistic action, to define the most appropriate approach (permissible daily exposure (PDE) or linear extrapolation) and how this was used to define the ICH M7 addendum.


This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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