ICH Q7 does not specify a need for physical and secure segregation. Both [ICH Q7, Sections 4.14 and 10.11] include the provision for the use of alternative control systems for storage of rejected material. Whatever control system is used, the purpose should be to prevent the unintentional or unauthorised use of the rejected material [ICH Q7, Sections 7.44, 10.11, 14.1].
