Expert: Michael Anisfeld - 11/15/2007

Question
I want to ask about retained samples.When the drug product packed it may have many consignees.Is it necessary to sample from each consignee a reserve sample?(If yes): what is the quantity for all consignees?

Answer
It frequently happens that a single batch of product is packed in the same primary packaging, but the secondary packaging (tech labels, cartons, etc.) are different for different markets. Where this is tech case, then you only need to keep one example for the retained sample - you do not need to keep a sample of each different labeling.

BUT ... the above only applies where you have the same primary packaging configuration for all different markets to which the batch is destined.

The batch records for each different secondary packaging will, of couse, have copies of the specific labeling used on each different packaged batc.

Hope this helps.