Hello,
Can any one tell me what is the difference between Exhibit Batch and Pilot Batch?
Regards,
Tapan P. Gajjar
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 scucessful.
No one can afford a Stability study in Commerial 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.
Thank you Sir.
Regards,
Tapan Gajjar
[quote=DURGA PRASAD]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 scucessful.
No one can afford a Stability study in Commerial 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.[/quote]
can we challenge the process parameters in exhibit batch?
Thats a brilliant question.
Yes, you can… provided you are with in your design space and you work on concepts of QbD from inception of the product concept.
Otherwise you will have to prove why you have changed and what other parameters are getting effected by this change and also product quality out come.
In QbD you are free to give your design space. It by having a mathematical formula or a simple parameter.
Regulatory agencies will look into those values based on your Science and Risk based documents and will take an independent descision to approve or rejects your finds and conclusions.
[quote=DURGA PRASAD]Thats a brilliant question.
Yes, you can… provided you are with in your design space and you work on concepts of QbD from inception of the product concept.
Otherwise you will have to prove why you have changed and what other parameters are getting effected by this change and also product quality out come.
In QbD you are free to give your design space. It by having a mathematical formula or a simple parameter.
Regulatory agencies will look into those values based on your Science and Risk based documents and will take an independent descision to approve or rejects your finds and conclusions.[/quote]
before doing exhibit batch,can we do the blend uniform study or not?
Thank u sir,
can we do the hold time study of exhibit batches ?
[COLOR="#000000"]If it is exhibit batch you can do the hold time study provided all parameters are met. You need to perform such hold time studies nearer to actual manufacturing conditions and handling operations.
Its a rather tough question to handle.
In this situation even if a particular vessel changes in case of a parenteral product or a particular size of a drum or Material construction of a drum to hold the product/products changes, it gives more room for regulators to ask due to the difference in holding abilities by the operators for that particular batch when compared to actual manufacturing conditions.[/color]
Using multiple active pharmaceutical ingredient lots and exposing some batches to worst-case processing conditions such as maximum hold times and sterilization temperature and time should be considered when manufacturing stability batches. The batches should be manufactured at the proposed site for commercial production, using equipment equivalent to commercial use.
For proposed products with multiple presentations, manufacturers may consider a matrixing or bracketing design approach described in ICH Q1D.
Difference between exhibit batch and Validation batch ?
thank you so much sir,