Manufacture volume

[ireligil]

Hello all friends.

I will make process validation for our liquid product. I will make 500 liter. My question is; if I make validation 500 liter, can i manufacture 350 liter witout validation?

Thanks for all answer.

[ireligil]

Who can help me?

Best regards.

[Luqmanikram]

Hi,
No need to perform re validation, only confirmation study will be required.
Regard
M. Luqman

[ireligil]

[quote=Luqmanikram]Hi,
No need to perform re validation, only confirmation study will be required.
Regard
M. Luqman[/quote]

Thanks for your answer. What i must will make for confirmation study? which test need for confirmation?

[ireligil]

Who can help me? What can i do for confirmation? which test need for confirmation?

[Luqmanikram]

During conformation study a single batch manufactured under protocol and subjected to validation testing {e.g. finished product segment (Top, Mid & Bottom etc.) testing as required). One (1) confirmation trial is required to constitute a Confirmation Study. Normally this is a commercial batch, releasable upon approval of the confirmation report.

[ireligil]

@Luqmanikram

During conformation study a single batch manufactured under protocol and subjected to validation testing {e.g. finished product segment (Top, Mid & Bottom etc.) testing as required). One (1) confirmation trial is required to constitute a Confirmation Study. Normally this is a commercial batch, releasable upon approval of the confirmation report.

Thank you friend.