Expert: Michael Anisfeld - 4/10/2008

Question
A bulk of tablets was made 2 months ago. It has been waiting since then to be put in the primary package. Do we need to test again, if yes what parameters?

Answer
FDA allows up to 30 days storage without the need for supporting stability data on the bulk. as such you cannot release the batch without supporting stability data.

Start your packaging, and quarantine the material. Simultaneously start an accelerated 3 month stability study. If after the 3 months study the data mimics original ANDA data, release the batch - if it does not, then do not release the material.