Formurex maintains standard environmental chambers according to the ICH storage conditions, such as 25°C/60%RH, 30°C/65%RH, 40°C/75%RH, -20°C, and 5°C. These chambers are monitored 24X7 and have a back-up power generator.
Stability Studies
Stability Studies
Draft/review/approve stability protocols.- Prepare and update stability reports. Monitor stability through trend charts with expert input on statistical analysis. Update and consult with Sponsors on analysis of stability trends.
- Ensure expiry dates on lots of DS and DP intended for clinical use are updated on a timely basis with appropriate amendments to certificates of analysis (COA). Communicate expiry date changes to stakeholders.
- Prepare stability tables and charts for regulatory submissions as directed by the client.
