By arzu on Monday, August 2, 2004 - 01:22 am:
Hi,
I have been working in quality controls of drugs and I have a problem.
According to GMP rules can a batch be divided? (Taking half of the batch a firm produces tablet A for themselves and with the other half of the batch they produce tablet B for another company. Tablet A and B have the same serial number and of course the same formulation and strength.)
I will be happy if you can help me.
Thank you for now.
By popeye on Thursday, August 5, 2004 - 02:58 am:
No it cant be done. The batch has a separate identity. The batch cannot be divided, because when you are supplying to separate vendors, the batches have to be identified separately and they need to have separate batch manufacturing records, which is not possible in this case since you want to divide one batch into two.
Regards,
Popeye