Offering comprehensive and cost-effective GMP stability testing, study management and stability storage services in accordance with cGMP and ICH guidelines
Stability testing is essential when developing a pharmaceutical product. Stability testing determines how well the drug product reacts when exposed to conditions such as heat, pH, humidity and radiation. It is critical for patient safety to understand how a drug product will modify over time and guidance is required on the storage and disposal of the product.
Our all-inclusive stability service encompasses protocol design, analytical method transfer, study management, sample analysis and QA approved reporting, taking into account transport simulation and in-use stability programs.
Our UK, European, and US state-of-the-art, walk-in stability chambers provide 300m3 of ICH-compliant, climatic storage facilities to satisfy all requirements.
- -80°C and -20°C freezers
- 5°C refrigerated storage
- 25°C/60%RH long term stability storage
- 30°C/65%RH intermediate stability storage
- 30°C/75%RH climate zone IV
- 40°C/75%RH accelerated stability storage
At any given time, our dedicated team supervises 350 or more stability programs. From early phase material to validation and commercial batches, all conditions are continually monitored and employ back-up systems to ensure a secure and controlled environment.
As part of our release testing activities, we also offer reference standard management which is a critical aspect of drug development to ensure there are no avoidable delays. Find out more here.