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Validation of pilot batches

Hi,

I would like to know follwoing points for solid oral dosage for non regulated export market purpose.

1] Can we take pilot batches (3 batches) as process validation and one batch of the same product as commercial scale ?

2] If yes, shall we keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.

[quote=ozamits]Hi,

I would like to know follwoing points for solid oral dosage for non regulated export market purpose.

1] Can we take pilot batches (3 batches) as process validation and one batch of the same product as commercial scale ?

2] If yes, shall we keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.[/quote]

Dear Qzamits<
See

http://www.askaboutvalidation.com/forum/showthread.php?t=570

Thanks

[quote=ozamits]Hi,

I would like to know follwoing points for solid oral dosage for non regulated export market purpose.

1] Can we take pilot batches (3 batches) as process validation and one batch of the same product as commercial scale ?

2] If yes, shall we keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.[/quote]

Dear, yoy r repeating the same Question are u not satisfied with previous answers, if not then elaborate your Q a bit more.

NO NEED TO KEEP 4
BATCHES.
ONE SUCCESSFUL BATCH U CAN PUT INTO STABILITY STUDY.

PRASAD
prasadaparajit@rediffmail.com

[quote=ozamits]Hi,

I would like to know follwoing points for solid oral dosage for non regulated export market purpose.

1] Can we take pilot batches (3 batches) as process validation and one batch of the same product as commercial scale ?

2] If yes, shall we keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.[/quote]

[quote=pvalidation]NO NEED TO KEEP 4
BATCHES.
ONE SUCCESSFUL BATCH U CAN PUT INTO STABILITY STUDY.

PRASAD
prasadaparajit@rediffmail.com[/quote]

Dear Parsad,

It is better practices that stabilty studies must be conducted on 3 batches.

See my earlier post
1)Pilot batches may be used in the process development and optimazation stage ad it also use as support of formal stabilty studies Ans some times it also use in clinical and pre-clincal studies. It should be 10% iof actual commercial batches.
2)For pilot batches, gennerally different manufacturing equipments are used for pilot bathes , so PV must be done on actual three commercial batch .
3) Stabilty studies should be perform on lab scale batches before the launch of product (6 month accelerated and one year long term) then launch the product fter that ongoing stabilty must be perform on pilot batches and PV batches.