Product Development Services- Stability Studies

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