Where an intermediate leaves the manufacturer's material management system with an expiry or retest date, supporting stability information such as published data or test results should exist. An API's expiry or retest date should rest on evaluation of stability study data, a retest date being the usual practice. Preliminary dates may rest on pilot batches if those batches use a method and procedure simulating the commercial process and the API quality represents commercial material. A retest should use a representative sample.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.