In-use studies
In-use tests simulate the application of a product in real-life conditions to determine its microbiological or physicochemical stability and to establish a shelf life after opening, if necessary. The focus is often on products for multiple use, where the removal of the product poses a microbiological risk and there is a potential danger to health during use via the potential contamination with pathogenic microorganisms. Labor LS offers you the following approaches here:
- Development of a test design tailored to the product and its application (if necessary, integrating specific microbes present at the place of application)
- Preparation of a corresponding test plan including microbiological and physicochemical tests
- Customized reporting
In doing so, we comply with the requirements of in-use stability tests for medicines for human and animal use as set out in the EMA’s (European Medicines Agency) CPMP and CVMP guidelines or the requirements of the cosmetics regulations:
- CPMP/QWP/2934/99 Note for Guidance on In-Use Stability Testing of Human Medicinal Products
- EMA/CVMP/424/01 Note for Guidance on In-Use Stability Testing of Veterinary Medicinal Products (Excluding Immunological Veterinary Medicinal Products)
- CPMP/QWP/159/96 corr. Note for Guidance on Maximum Shelf-life for Sterile Products for Human Use after First Opening or Following Reconstitution
