Validation and qualification are important tools that must be used to ensure that the protocols and equipment used to prepare and bank cell and tissue grafts are safe, effective, and fit for purpose. When applied correctly, they can reduce the need for destructive quality control testing and improve the efficiency of a tissue bank's operations. This chapter covers the principles of the planning, performance, and control of validation and qualification studies and, by reference to actual protocols, demonstrates how they can be applied in practice.