By Arzu on Tuesday, August 3, 2004 - 04:09 am:
Hi,
I have been working at quality control of drugs.I need your advices.
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)
Thank you for now.
By Narendra on Friday, August 6, 2004 - 11:37 pm:
Hi Arzu
You can not do this way it is agianst GMP and Regulatory requirement.
By klong on Thursday, August 12, 2004 - 01:00 pm:
Hi Arzu,
We used to do something similar, but we had a batch number and a packaging number. Batches A and B would have the same batch number, but different packaging numbers. The packaging number would appear on the label.