karen-reissfelderipsen-comParticipantNovember 13, 2019 at 9:23 amPost count: 1
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?John O’NeillModeratorDecember 24, 2019 at 1:12 pmPost count: 53
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.
J. O’NeillksparkmanParticipantNovember 15, 2022 at 1:55 pmPost count: 3
This is the exact topic I was looking for! Do you typically apply the same retention sample strategy for clinical and commercial products?John O’NeillModeratorNovember 18, 2022 at 10:04 amPost count: 53
I personally would apply the same retention strategy for clinical and commercial products, but opinions may vary between your Quality colleagues and regulatory agencies (even between colleagues within the regulatory agency) In pursuing any strategy, put together your best possible justification (science/regulation/industry best practice-based) and sell it to your Quality Assurance and Regulatory brethren. You won’t want to be standing alone if some regulatory authority objects a few years down the road. (Make sure that your justification and multi-discipline approval are well documented and retrievable). As always, this forum welcomes all applicable input from our subscribers.
- You must be logged in to reply to this topic.