Stability check and storage
Stability tests in accordance with ICH Q1A (R2) are a key component in the development and approval of new active substances and finished pharmaceutical products. We would be happy to advise you, define your stability program including analysis and support you during the entire life cycle of your drug, from development to production.
AZ-Biopharm conducts stability studies on active substances and drugs according to the guidelines released by the following international organizations:
- ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
- EMA (European Medicines Agency)
- WHO (World Health Organization)
In general, we provide the following ICH standard conditions.
The AZ-Biopharm offers stability testing according the WHO climate zone definitions:
The stability tests carried out by AZ-Biopharm also include those for stability after the package has been opened (in-use and follow-up stability of multidose packages) and the stability test of active substances and pharmaceuticals under daylight conditions (photo stability, ICH Q1B). AZ-Biopharm is also authorized and equipped to carry out stability tests on narcotics and highly active and toxic substances.
All climate cabinets, refrigerators, freezers and ultra-freezers are connected to an alarm system for temperature monitoring and connected to an emergency power generator, which automatically takes over in the event of an interruption in the power supply.