Who should attend?
R&D, QC and RA department personnel
Technical staff involving in method development and validation
Quality departments supervisors
Topics Covered:
Impurities in drug substance
1.1 Origen and classification of impurities in drug substance
1.2 Potential impurity profile
1.3 Characterization of impurities
1.4 Guidelines for impurities control
Impurities and degradation products in drug products
2.1 Degradation impurities
2.2 Drug-excipient degradation products
2.3 Qualification of impurities and degradation
Setting and Justification of impurities and degradation specifications
3.1 ICH Q3A and Q3B thresholds
3.2 ICH Q6 guideline for specification
3.3 Case studies for specifications settings
Genotoxic impurities
4.1 ICH M7 classification of impurities
4.2 QSAR and Ames test
4.3 Setting specifications for genotoxic impurities
Forced Degradation and mass balance
5.1 Degradation patterns for drug substances
5.2 Design and reporting forced degradation study
5.3 Mass imbalance troubleshooting
Residual solvents
6.1 Classification of solvents as per ICH Q3
6.2 Setting specifications for residual solvents
Analytical Methods for impurities and degradation
7.1 Development of stability indicating methods
7.2 Validation of analytical methods
