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,
in general for closing of process change control like change in manufacturing process, introducing of new equipment changes, and raw material quantities changes can closed after completion of three consecutive successful batches, If all the quality and yield results were well with the specifications the same final analysis sheets shall attached to the change control and prepare risk re-assessment and conclude about the acceptance of the change proposed.
Dear kadambari.rakesh ,
Thanks for the sharing. We did have these practices in place. However, one of my difficulty is when there is a minor change such as to add one ABC tableting machine. Let’s say there will be 20 products using this machine, thus packing batch records for the respective products have to be revised to include the ABC tableting machine.
In this case, I will need to wait and collect all the 20 products packing batch record to be attached (related page only) in the change control and closed. Am I doing the correct way? It is very consuming time…Is there any other better options?
I will just assume that you meant to say manufacturing batch records not packaging for a tablet press.
Also, I do think it would be easier and give better tractability to write a separate change control for batch record changes than trying to tie it into a equipment change control.
Thanks for the reply. Yes, you’re right. It is batch manufacturing record for tableting process. I get your point to have a particular change control for particular change instead of few changes are raised in a same change control.
I did found it is much easier and I am implementing this practice to my company’s existing change control system.
Thanks and regards,
Better to use electronic tracking with validated software ; it will be surely maintain traceability and remind you on time for pending work related to particular chaange. Many software having facility to attach sanned supporting document will helps for better tracking