This week we will be going over the following subjects:
Overview of Drug Product Validation
- Process Design
- Process Validation
- Continued Process Verification
Overview W.H.O Drug Development Validation Process
- Overlaps with other internationally recognized regulatory agencies
Process Characterization and Elements of Validation
- Define process control, CPP, NOR, and CMA
- Risk Assessments
- Process Performance Qualification
- Comparability Studies
- Process scale down/up models
Overview of Analytical Method
- Accuracy
- Precision
- Specificity
- Linearity
- Range
- Detection limit
- Quantitation limit
- Robustness and ruggedness