Good Evening to all.
My question is, earlier we have initiate one change control to execute the validation caimpaign with 100 kg batch size and with same we was manufactured 2 batches.
Now we have no enough quantity of input KSM i.e. Less than 100 kg. Hence, we can not complete validation of 3 batches. But we need to take 3rd batch which will less input KSM. So, how can handle this. Can i close previous validation by prering validation report. And for less input, can i initiate one change control?
If any change need to initiate of batch size either validate batch size or not , we need to raise CC with impact analysis i.e. increasing/decreasing batch size effect critical quality attribute for process, equipment etc.
Note :If you plan 1/10th batch size increase/decrease is not advisable as scale up/down play role in important CQA a lot with same size equipment.With revised batch you need to work on fresh validation batch
Previous validation can not be closed if its is a new product. If its is an existing product, you can choose concurrent validation approach.
For the less qty KSM you have take the batch under deviation
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