Stability Community

What is the common practice for study initiation requirement?  I have seen "initiation within 2 months from manufacturing date" or " 30 days from release testing".  

Appreciate inputs from anyone.

Our SOP has the 30 day rule.

If we miss that 30 day window, we can't use the release test data for T=0, but will need to test T=0 again.

We use Initiation within 60 days from Batch Sterilization Date (Note: we are Med Device CFR820 not CFR210/211).

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