Stability studies

Can we discontinue stability study if party said discontinue further study without any reason. please explain procedure for discontinue

You have to prepare SOP for stability studies as per ICH guidelines.Explain discontinue procedure in SOP. if you observed significant change then prepare summarised result and remark. After that prepare new protocol and keep sample again for stability study.

I agree with previous remark, but if you are a CMO organization and your client just tells you to stop without reason, be sure to have this communication in writing. Initiate change control for discontinuation, use the communication with the client as justification. Don’t think there is a lot more you can do.

You can discontinue the study based on a written communication from the sponsor. Take a change control. Send a copy of the change control to the sponsor. Get it back signed and dated. Justify the reasons why the study is being continued. Close the change control.


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