H
Hi, all -
This might be a little confusing ...
My company is planning an IND study on a Blood Donor Screening Assay. These assays are regulated as Medical Devices.
It is clear the 21CFR820 regulations apply to the GMPs/Quality System for the manufacture of our assay kits.
Our IND study includes running x number of samples through our assay. So what regulations describe the necessary GMPs and Quality System for the actual running of the assay as part of the IND??
I'm sure in many ways they are similar, but I am performing a Gap Analysis of our current processes and the GMP requirements, and I'd like to be able to reference exact QSR sections when I provide feedback.
It's easy to say "we didn't use the correct revision of the SOP describing manufacturing our kit, so we didn't comply with 820.40 (a)." But if we used the wrong revision of an SOP used in running the samples in the IND, what regulation did we miss?
I've been searching the FDA website, but I obviously haven't entered the magic combination of keywords to get the answer I need.
Thanks. And please let me know if I'm making this far more complex than it has to be.
H_H
This might be a little confusing ...
My company is planning an IND study on a Blood Donor Screening Assay. These assays are regulated as Medical Devices.
It is clear the 21CFR820 regulations apply to the GMPs/Quality System for the manufacture of our assay kits.
Our IND study includes running x number of samples through our assay. So what regulations describe the necessary GMPs and Quality System for the actual running of the assay as part of the IND??
I'm sure in many ways they are similar, but I am performing a Gap Analysis of our current processes and the GMP requirements, and I'd like to be able to reference exact QSR sections when I provide feedback.
It's easy to say "we didn't use the correct revision of the SOP describing manufacturing our kit, so we didn't comply with 820.40 (a)." But if we used the wrong revision of an SOP used in running the samples in the IND, what regulation did we miss?
I've been searching the FDA website, but I obviously haven't entered the magic combination of keywords to get the answer I need.
Thanks. And please let me know if I'm making this far more complex than it has to be.
H_H