The Impurities Workshop Part II and III - Live Online Training Nirosamine Impurities & Elemental Impurities

The Impurities Workshop Part II and III - Live Online Training

Course No 20040

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

All times mentioned are CEST.

Costs

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Speakers

Dr Karl Abele, Solvias AG, Switzerland
Dr Cornelia Nopitsch-Mai, BfArM, Germany
Dr Ulrich Rose, Formerly EDQM, France
Jürgen Martin, Martin-Consulting, Germany
Dr Ulrich Rose, Formerly EDQM, France
Dr Andrew Teasdale, Astra Zeneca, UK

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Programme

Part II: Nitrosamine Impurities
 
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
Analytical Solutions for Monitoring Presence/Formation of N-Nitrosamines within APIs and Drug Products
  • Detection limits requested by in Article 5(3) of Regulation EC (No) 726/2004
  • Techniques used for analysis of non-API related N-Nitrosamines
  • Formation of N-nitrosylated APIs in drug products
  • Analytical methods used for quantification of N-nitrosylated APIs in drug products
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.

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
 
Part III: Elemental Impurities
 
European Pharmacopoeia Activities (Policy) on Elemental Impurities – an Update
  • Implementation of Q3D in Ph. Eur.
  • Changes in individual and general monographs
  • Harmonisation of general chapter 2.4.20
  • Second phase for revision of excipient monographs
Risk-Based Approach for Elemental Impurities in the Supply Chain
  • APIs, excipients, packaging materials impacting the purity profile
  • Evaluation of supply chain processes
  • Risk analysis as evaluation tool
  • Audits and monitoring programs as important sources
  • Testing strategies
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.

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