2023-10-05T05:30:16
17.0 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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