11th Sep 2012, 09:12 AM
IMPs and same/different batch
Should the investigational medicinal products used in a clinical trial be always from a single batch?
Can reference drug from different batches of the same MAH and manufacturer be used in a clinical trial? If yes, what additional documentation(s) need to be provided in this scenario?
21st Sep 2012, 05:13 PM
Would be good to check with GMP. The BARQA GMP website offers a Q & A section. I suspect that it is not a requirement to use a single batch. but It would be necessary to submit a CofA for each batch.