Dr. Ulrich Rose
Straßburg
Referent:innen
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
All times mentioned are CEST.
Technical Requirements
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Programm
Gesamtes Programm als PDF herunterladen
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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