Azopharma provides stability programs which are geared towards high throughput production combined with detailed compliance strategies.
Stability Testing
- APIs
- Finished products
- R&D preliminary stability (protocol development, testing and evaluations)
- Setting of specifications
- High throughput QC release/stability
- Clinical trial material
Stability Storage
- Walk-in/Reach-in units
- Full ICH conditions
- Customized cycling conditions
- Continuous monitoring
- Continuous alarming
- Generator back-up
- IOPQ with mapping
We anticipate potential problems and take appropriate and preventative corrective actions:
- Data variability controls
- Predictive aberrant data controls
- Data trending
- Expiration dating
- 3-day pull windows
- 2-week test windows
- 4-week reporting windows
- Comprehensive reports