QC Testing and Stability Monitoring for Commercial Manufacturing
The future of CMC regulatory review is based on Quality by Design (QbD), and the CMC Regulatory Decision is based on CMC Quality & Performance. Stason has quality control systems which require strict adherence to cGMP regulations. Total system quality is monitored from sample receipt to report generation. Stason offers quality control (QC) testing for Active Pharmaceutical Ingredients (API’s), pharmaceutical intermediates, excipients, and finished products.
Stability storage conditions meet ICH guidelines. Each cGMP environmental chamber operates independently, with separate temperature controls, and monitored continuously through a validated environmental monitoring system. All storage chambers are supported by full generator back up in case of power failure.
ICH Stability Chambers
- 25°C/60%RH
- 30°C/65%RH
- 40°C/75%RH
- Customized Conditions (for example: Zone IV).
Stason performs release and stability testing for small molecule drugs (brand, generic) and diagnostic products. Appropriate sampling and testing methods are determined, documented and executed. Analytical services supporting stability programs include: long-term stability testing, accelerated stability testing, comparative stability testing, and forced degradation studies.