Eva lee
Registered
Hi to Everyone.
We have complete our process validation of our product using the full scale batch size. However , I dont think we could product very just the batches size of what we validated for each batch.
So, Which is the range for the validated batch size(for example ±5%, 10%) is acceptable?
Is there a official document issued by any FDA/MOH in where is defined the range .
Do you also have information on this issue?
Thank you for you support.
We have complete our process validation of our product using the full scale batch size. However , I dont think we could product very just the batches size of what we validated for each batch.
So, Which is the range for the validated batch size(for example ±5%, 10%) is acceptable?
Is there a official document issued by any FDA/MOH in where is defined the range .
Do you also have information on this issue?
Thank you for you support.