When is an FMT Treatment Ready for Use? Health Monitoring and Material Release

Stool banking is a complex, multi-step process that includes screening and monitoring donor health as well as manufacturing fecal microbiota transplantation (FMT) preparations from donated stool. To help ensure that FMT preparations meet the stool bank’s quality and safety standards, a Quality Department reviews all information associated with an FMT preparation and its donor to verify that it is suitable for patient treatment. This paper outlines and discusses basic quality checks that FMT material should pass before it is released for clinical use.