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.