Azopharma
 
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
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