Microbiology-PTM-OMA_Modules_1-5

Product Stability

• Study to support the shelf life statement and confirm that there is no  observable change in performance of the method over the shelf life  under normal storage conditions. Three possible study designs are: 1. Testing is performed on lots representing the full span of the  shelf life of the kits (newly manufactured, middle of term, near  expiration date).   • This design allows the stability study to be performed concurrently  with the product consistency study when unique lots are tested 2. Testing is performed on 1 lot by testing at least 5 time points  over the shelf life of the kit 3. Preliminary stability testing is conducted using accelerated  studies  • Provides only a rough estimate of shelf‐life • Real time data supporting the entire shelf life of the kit under  normal storage conditions must be submitted as soon as available