Impurities and Degradation in Drug Products

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