Syrup Process Validation batch

Production
1

What must be the PV batch size to be taken for syrup as per WHO TRS guidelines ?
The commercial batch will be of 300 lt.

2

@Reshma Process validation should be done on commercial batchs.

1 Like
3

Thank you for the reply.

That means for liquids the process validation can be taken directly on commercial batch.
But there is a problem as i m taking PV batch for registration purpose therefore the whole commercial batch will have no sale and will be kept as inventory .
Therefore can u confirm if a 30 lt batch (3 batches) for PV will be acceptable by MCC if the commercial batch size is 300 lt.