In use stability: This section should provide information on in use stability studies for one lot reflecting actual routine use of the device (real or simulated). This may include open vial stability and/or, for automated instruments, on board stability. In the case of automated instrumentation if calibration stability is claimed, supporting data should be included. Such detailed information should describe: (a) the study report (including the protocol, acceptance criteria and testing intervals); (b) conclusions and claimed in use stability.
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