Exhibit batch is one which can be manufactured in production
plant or even in pilot plant which have similar equipments such as in
production facility. An exhibit batch is also called LATE PILOT BATCH which is
used to provide the major stability data as per ICH guidelines to submit for an
ANDA application.
A pilot batch is one which is primarily used for scale-up and optimization studies.
You cannot take up an EXHIBIT BATCH until a (pilot) Scale-up batch is completely successful.
No one can afford a Stability study in Commercial batches as it has a long lapse of time and its material will be wasted. That is the reason Exhibit batches are used by pharma/biopharma companies to save time and money.
A pilot batch is one which is primarily used for scale-up and optimization studies.
You cannot take up an EXHIBIT BATCH until a (pilot) Scale-up batch is completely successful.
No one can afford a Stability study in Commercial batches as it has a long lapse of time and its material will be wasted. That is the reason Exhibit batches are used by pharma/biopharma companies to save time and money.
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