My question is regarding CFR reserve samples. Our Bulk Drug Product (BDP) is manufactured at our site in Cambridge. The BDP is shipped to a filling site. The BDP is filtered and then the Drug Product vials are filled. There is no process changes between BDP and DP. Do we need to take reserve samples for both BDP and DP?
Good question, and the spectre of an inspector asking to see the bulk reserves pushes one towards a cautious option, but then space, resources and annual evaluations of the samples give us good reasons to refrain from this practice. I would like to hear other opinions, but for now I’m voting on the side of retaining only finished product reserves. They contain the residual cumulative effects of previous processing. The only scientific advantage I would see in having the bulk reserves would be a faster reveal as to whether an emerging problem began with the bulk phase or originated with the packaging phase.