From the planning stage to the documentation, we undertake the entire procedure of stability testing on active substances and finished medicinal products for our clients. We can also design in-use stability testing, storage at varying temperatures (transport stability), stress tests and photostability studies to order. Our clients thus profit from our many years of experience and the possibility of transparent cost monitoring over the entire duration of a stability study.
We advise and support our clients with stability studies during the whole of the development and marketing phase (product life cycle). Our clients require regulatory stability testing, such as ICH-compliant exploratory studies and confirmatory studies, for marketing authorisation. For stability testing of all currently marketed products, we perform GMP stability monitoring (ongoing studies).
The laboratory is suitably equipped to perform photostability testing under defined climatic conditions and stress tests under specific climatic conditions and stresses.
At the beginning of a client order, the test sample requirement must be determined and the test protocols drawn up.
On request, specific methods are developed and validated.
Storage of the test samples takes place in qualified climate-controlled facilities with continuous recording of the climatic conditions and an alarm safety system.
Timely removal from storage, analytical testing of the test samples and GMP-compliant documentation of all the relevant stages form part of our daily routine.