CFR Reserve Samples

[karen-reissfelderipsen-com]

#3952

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’Neill]

#4613

Hi Karen,
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’Neill

[ksparkman]

#22457

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’Neill]

#22460

Hello ksparkman,
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.
Best regards,
John O’Neill

[joao4515]

#25440

As a Sponsor, I would 100% agree with you, John.

As a CDMO, I would add that the Client should have stated their retention plan as part of the contract. This helps to provide a cost structure for storage from the CDMO to the Client/Sponsor.

Cheers,

J

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