Validation of pilot batches

GOOD VALIDATION PRACTICE (cGVP)
1

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, we have to keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.

2

[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, we have to keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.[/quote]

No!!! Pilot batches may be used for the process development and optimization of manufacturing process. It is mostly 10% of the Production scale batch. For process validation is done for (Typically) 3 production scale batches, as the term Validation is reserved for the final verification.

Yes!!! U will have to keep all three batches for stability as post marketing stability samples.

3

[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, we have to keep all 4 batches for stability studies ?
If no, what is the alternate ?

Thanks.[/quote]

Dear Ozamits,
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.

4

[quote=Shahid Ali]No!!! Pilot batches may be used for the process development and optimization of manufacturing process. It is mostly 10% of the Production scale batch. For process validation is done for (Typically) 3 production scale batches, as the term Validation is reserved for the final verification.

Yes!!! U will have to keep all three batches for stability as post marketing stability samples.[/quote]

So, validation of pilot batches is not necessary.
Would you please tell me how to have more information from pilot scale study without validation?
Thanks