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Stability Studies


Stability Studies

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Program designed to meet FDA, ICH and other worldwide regulations

Services Scope

  • Stability studies for IND API and clinical trial GMP batches
  • Primary/registration stability/formal stability studies (FSS)/long term stability studies (LTSS)
  • Package evaluation by matrix design
  • Post approval commitment – commercial stability

Storage Facilities

  • 850 m3 (17 walk-in chambers and 11 reach-in chambers)
  • ICH guidelines: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH and light or customized conditions including 2-8°C, -20°C, -80°C, 25°C/40%RH, 30°C/35%RH, 40°C/20%RH, 50°C/40%RH, freeze cycling
  • Stability rooms and chambers are qualified (IQ/OQ/PQ & Mapping) & calibrated
  • Backup power supply
  • Dual time temperature & humidity monitors with alarm system
  • Dedicated chamber managers for qualification and preventive maintenance

Free Trade Zone for Stability Programs

  • Shipment logistics: 3-4 days globally
  • “Green Channel” for customs clearance
  • Decreased tax burden – potentially millions of dollars from the lack of duty and VAT expenses for registration/commercial programs
  • “China for Global” as well as “China for China” submission

 

Dedicated Project and Process Management

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