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

The Impurities Workshop Part II and III - Live Online Training

Seminar Nr. 20040

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

All times mentioned are CEST.

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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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