We hold a manufacturing authorisation according to section 13, paragraph 1, of the German Drug Law (AMG) for the release of drug products and conduct analytical testing for the batch release and EU release of active ingredients and ready-to-use products in our GMP- and FDA-certified lab.
We offer stability testing of ready-to-use drug products and active ingredients according to the applicable European and international guidelines. In addition, we devise matrixing and bracketing designs and perform in-use stability and photostability studies. We advise on stability concepts and shelf-life specifications in product development and life-cycle management.
We have extensive capacities for the GMP-compliant stability storage at 25°C/60% relative humidity, 30°C/65% relative humidity, 30°C/75% relative humidity and 40°C/75% relative humidity, 2–8°C or deep-freeze storage of –18°C to –80°C. Specific climate conditions that deviate from these can be prepared upon request. All climate chambers and cabinets are monitored 24/7 in compliance with GMP.
We conduct the entire stability management for you and prepare the stability results in line with GMP and the marketing authorisation with evaluations, tables and charts. If required, we can enter the stability results directly into your templates and/or CTD modules.