Dear team,
Can i SOP Effective with open change control???
No CCR Should be closed out.However the SOP can be made effective by initiating a CAPA for extended actions / pending under impact actions with a clear cut Target Date for implimentation .The system shall be reviewed for compliance periodically per laid down SOO for Review of Quality System Review …
Hope it’s clear… KR Insights…
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No issue but as per regulatory practice any SOP can be effective based on the implementation of the proposed changes and successful completion of training after only the change control should be closed
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