Change Control of BMR

I want take change control for new BMR? & want to explain justification for proposed changes
but i have no idea for the same tell me how i will work out on this topic so my compliance will be done

Fill change control form as per company documentation.

what is the reason of new BPR?
is it new product ?
change in batch size?
change in process?

As the Bmr is new , being prepared for the first time ,justify proposed change with the reason such as new production introduction,MFR reference etc which triggered to raise the change control .

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Make clear whether the product is new or there is any change in the process parameters or change in batch size of the existing product.

Justification: To prepare new BMR for manufacturing of new product on basis of MFR.

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You should make change control with title of induction of new product xyz in ABC company.
Make action plan accordingly
Manufacturing and packaging (BMR & BPR) Protocol Will be prepared.
Process validation of 3consutive batches Will be conducted. etc etc

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