Good day. It would be thankful if anyone of you can share your handling practice in the change control process.
When a change control is raised, we need to record all the detail of change such as what is the change, reason for change, risk assessment, change classification, necessity of validation/re-validation, regulatory submission (if relevant), and so on…
My current situation is like that:
When a change is made, for example, to use new filling machine to run several products. QA manager and change control committee will assign the necessary task to carry out the change. The tasks would be:
- To change/revise the batch record (those relevant only)
- To perform IQOQPQ
- To update the VMP (for equipment qualification and PV respectively)
- To perform validation for the filling process (3 batches)
- To perform process capability for the new filling machine and compare the results with the previous filling machine-3 batches
- To perform stability study
- To train the operator/relevant personnel to run the machine
Imagine if the batch record to be revised is for 50 products, the change control has to wait until the 50 batch record revised accordingly, and the task is signed off. BUT, there are still 3 PV batches, stability studies etc where take few months to years.
So, when all these tasks are to be completed then only QA can close the change control, it will seriously take a very very long time.
Is your also practicing in such way? Can someone please guide me how should I do in order to get the change control signed off as soon as possible meantime it is still GMP compliance.
Thanks and regards,