Experiments relating to the physical, chemical, biological, biopharmaceutical and microbiological characteristics of a medicinal product, during and beyond the intended shelf life and storage period, and which are performed on samples maintained under storage conditions similar to those that will be available on the intended market. The results are used to determine the shelf life, confirm the intended shelf life and recommend storage conditions.
According to ICH Q1A, mandatory requirement for the approval of new products, depending on the climate zone:
– Zone II: 25ºC/65%RH
– Zone IVa: 30°C/65%RH
– Zone IVb: 30ºC/75%RH
Drafting of stability protocols, sample analysis, stability reports…