Live Online: The Impurities Workshop - Part I and II

Live Online: The Impurities Workshop - Part I and II

Course No 18614

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Dr Gerd Jilge, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Grace Kocks, Lhasa Limited, United Kingdom
Dr Corina Nachtsheim, Quality Assessor, Germany
Dr Xaver Schratt, GBA, Germany
Dr Andrew Teasdale, AstraZeneca, United Kingdom
Dr Lise Vanderkelen, Nelson Labs, Belgium

Technical Requirements

For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Part I: General Strategies for Investigation and Control of Impurities on 01 December
Impurities Analysis and Qualification of Impurities in Drug Substances and Drug Products – General Overview
  •  Impurity profiling in synthetic drug substances
  •  Qualification of impurities
  •  Degradation studies
  •  Identification of chiral impurities, polymorphic phases and new impurities
  •  Residual solvents
  •  Impurities in starting materials and intermediates
  •  Pharmacopoeial tests and acceptance criteria
  •  Drug product specifications and parametric release
Analytical Method Validation for Impurities Determination at Various Development Stages
  •  Quantification of impurities
  •  How to define an impurity profile (stress tests)
  •  Reference substances
  •  Validation of methods at various development stages
  •  Statistical approaches to method validation (LOD & LOQ)
Presentation and Workshop: Analytical Techniques for Determination and Qualification of Impurities in Starting Materials and Intermediates
  •  Purity analysis by HPLC, impurity profile
  •  Residual solvents by GC
  •  Inorganic impurities (heavy metals, sulphated ash)
  •  For chiral compounds in addition: enantiometric purity and proof of the absolute configuration
  • In the Workshop the participants will learn which activities are necessary to characterize drug substances taking into account the following aspects:
  •  Analytical procedures are necessary for the characterization
  •  Experiments necessary to check the downstream impurities in order to justify acceptance criteria for the respective impurities
  •  Other impurities have to be taken into account
  •  Experiments to be performed in order to get a stability-indicating analytical procedure
Leachables and Extractables
  •  Why should Extractables & Leachables be assessed?
  •  Regulatory requirements in the EU and US
  •  Compendial requirements and  industry standards
  •  Safety qualification of Leachables and Extractables
Unexpected Impurities: Approaches for Investigation and Determination
  •  Is there such a thing as ‘unexpected impurities” or is there a lack of process understanding?
  •  Valsartan – overview of events
  •  Source of contamination
  •  Mechanistic understanding
  •  Examination of risk within other Sartans – overview of how to conduct a risk assessment and to identify key factors
  •  Are there other Mutagenic Impurities related risks?

Part II: Nitrosamine Impurities on 02 December
European Pharmacopoeia Activities (Policy) on Mutagenic Impurities with Focus on Nitrosamines
  •  Ph. Eur. General policy on DNA reactive impurities
  •  Control of Nitrosamines in Ph. Eur.
  •  Changes in individual and general monographs following the Sartan case
  •  New general chapter on control of nitrosamines
Root Causes for Nitrosamine Impurities and Other Mutagenic Impurities – Practical Approaches to Assess the Risks
  •  Development of a systematic risk based approach
  •  Key factors and the development of a decision tree
    •  API
    •  Drug Product
    •  Packaging
ICH M7 Safety Risk Assessment and the Cohort of Concern – How to Deal with e.g. Nitrosamines
  •  Principles of cancer risk estimation in ICH M7
  •  Why was the cohort of concern excluded from ICH M7?
  •  Applicability to use ICH M7 based cancer risk assessment to the cohort of concern
  •  Nitrosamines, why are they in the cohort of concern?
  •  Major risk factors for sources of nitrosamines in drugs
  •  Way forward to handle cohort of concern within ICH M7
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.

Nitrosamines and Other Genotoxic Impurities – Authorities' Expectations and Dossier Requirements
  •  The assessor’s approach: principles of toxicological assessment
  •  Structural alerts
  •  Limits and Permitted Daily Exposure
  •  The ALARP principle
  •  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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