Out of specification (OOS) ATMP
Sometimes an ATMP does not meet the quality requirements as laid down in the specifications of the Investigational Medicinal Product Dossier (IMPD). This is referred to as an out of specification (OOS) ATMP. In exceptional cases, an OOS ATMP may still be administered to the research subject.
Under section D7. Out of specification (OOS) ATMP of the standard research file, you will find more information (in Dutch) on what to consider in such a situation.