how should we handle closing of change controls, so that we have lesser number of open change controls?
At the time of change control initiation , we need to think about it through Impact analysis for any task related to change proposal i.e. trial /document revision/system updation, Tentative list of document /activity with initiation department or whole channel of activity , other deliverable action to support the closing Change control.
These will help you to closing the CC in time. If any hurdle raise we can justify with all concern.
If suppose we have reprocess validation batch, and waiting for 1 or 2 more batches to complete validation and close change control, then how could me close change control and validation for same, do we have to wait for another reprocess batch or there is any other alternative for same.
Maybe it is organization call, to define the criteria of change control and closing time line for that.
In recent last year few of the 483 already issued to firms regarding same topic.
Okay so in general what practice organization’s are following
First of all raise the change control with existing and proposed changes, impact analysis to be performed by all stake holders and action items to be identified based on the proposal. Once the change control is approved by QA, the changes can be implemented. Once all the changes are implemented, the same is being verified by QA. After satisfactory implementation. If the effectiveness check is required, the same has to be verified. After satisfactory completion of all identified action items, change control can be closed. Unless all action items are closed, change control cannot be closed.
If it’s a management call to close change control without completing the proposed validation batches what I have understood, probably there the management is serious about the Quality system.As per ICH Q10 , implementation of Quality system is the management responsibility and Change management is one of the element of Pharmaceutical Quality system.
So according to you, we don’t have to close change control without completion of all 3 validation batches
If it’s mentioned in Change control that 3 validation batches to be executed for some purpose then it cannot be closed.