Studies

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

Your contacts on this topic

We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts:

Dr. Carola Matthies
Challenge Tests and Validation Projects
+49 9708 9100-160
carola.matthies@labor-ls.de

Lisa-Antje Büttner
Challenge Tests and Validation Projects
+49 9708 9100-162
lisa-antje.buettner@labor-ls.de