Specification-compliant product quality around the globe and under the widest range of climate and storage conditions is an important quality characteristic of pharmaceutical products. It is a matter of nothing less than the trust and safety of the patients who use the products we make.
We inspect and test for all standard climate zones according to the guidelines of the International Conference on Harmonisation (ICH). Our quality assurance laboratory offers all conventional analytical methods for testing the quality of your product over the course of your stability study.
ICH guidelines give recommendations for stability test protocols, in particular temperature, humidity, and duration for various climate zones, in order to simulate a wide variety of warehouse conditions and obtain data and information such as how the quality of a product is influenced over time.
- Long-term testing: 25°C and 60% relative humidity
- Long-term testing / intermediate conditions: 30°C and 65% relative humidity
- Stresstest / accelerated conditions: 40°C and 75% relative humidity