Stability testing
Tailor-made solutions
Tailor-made solutions
All pharmaceutical development activities require thorough stability considerations. Our range of storage capabilities are fully compliant with ICH guidelines. Through our extensive experience in stability studies for all stages in the pharmaceutical product life cycle, Galenica offers support in the design and set up of stability studies, tailor made for your need with full regulatory compliance.
Our stability services include
- R & D preliminary stability
- Formal stability studies
- APIs
- Finished products
- Data trending
- Expiration dating
- Stability reports
Our stability cabinets are qualified to GMP compliance and operate independently with their own temperature and humidity controls. All storage chambers are continuously monitored by a computerized log system.
Galencia offers the below storage capabilities, fully compliant with ICH guidelines:
- -20°C/Ambient RH
- 5°C/Ambient RH
- 25°C/60%RH
- 30°C/65%RH
- 40°C/75%RH