Expert: Michael Anisfeld - 10/28/2009

Question
I am trying to determine if there are any rules FDA/Foreign that would require a retain sample for different bottle counts hat may have occurred over the course of several months/years if the same primary packaging configuration were used.  The labels would be different indicating a new lot number based on the new pack time and count but the materials are all the same.

Additionally, can you tell me if we packaged everything in brite stock, and then labeled at different times (new lot numbers based on when packaged) would retains be required?

Thanks in advance,
Jerry

Answer
Interesting questions.

21CFR211.170 on Reserve Samples states: "(b) An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling."

So, different bottle counts would have different lot numbers, and hence need to have retained samples from each bottle configuration.

With respect to "brite stock". Assuming the bottle count is the same, and the totality of the brite stock was packaged at the same time, then I would have reserve samples as follows:
a. to repeat chemical testing - just 2x bottles from the first labelled batch
b. for checks on physical labeling/cartoning, I could justify keeping one bottle of each different packaging (labeling) configuration.

I hope this helps.