Hello everyone,
I work for a dietary supplement company in the US. Management wants to explore reducing the frequency of 3rd party testing on finished products (for us, batch/lot are the same) from every batch getting micro/metals/purity to just micro. Or to reduce the frequency of 3rd party testing while keeping all of the aforementioned tests.
We already take in supplier COA for purity (as well as vendor qualification, etc. etc.)
We do identification testing in house (FT-IR, Raman)
I'm sure I'll need to offer more information (I always miss something) but for now, does anyone have any prior experience on what systems I'd need to make sure are robust to maintain compliance with 21 CFR 111 and cover our butts?