In MACO calculation as per PDE value minimum batch size of next batch and largest daily dose of next product will be next coming batch after 3 consecutive worst-case product or we will select it from Product matrix e.g. paracetamol tablet largest daily dose 4000 mg in a day as per product matrix. if we selected worst case as per PDE value than always we select paracetamol as largest daily dose despite paracetamol minimum batch size much more than other matrix products. kindly tell me how to select minimum and largest daily dose of next product for MACO calculation…
Whenever you are calculating the Maco considering worst case scenario,
You have to consider the minimum batch size of next product from Matrix and also largest daily dose from Matrix which gives most stringent MACO limit
Thanks a lot
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