How to justify reducing 3rd party testing on finished products?
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?
Hello FirstDay,
In my experience when making these kinds of changes it's all dependent on how you back up your decision. You want to test less, that's fine but do you have enough documentation to show the risk is low enough to make that change? Management not wanting to pay for testing probable wont fly with an auditor. In my facility we recently made a similar change and I'm sure it will come up during this years audit. I have two years worth of testing data along with risk assessments to show how we got there. Like you we are also getting COA's from a vetted and approved supplier. I feel very confident in the decision and the amount of data and documentation i have to back that decision up.
So as an example from your scenario with metals, do you have testing records that show a history of no metals or a very low frequency of metal presence? Metal detector records that show a history of no findings or very low frequency of findings? A risk assessment based off of data to show your reasoning fro why?
Again in my experience at least, that is the kind of thing auditors will look for on this.
Hope that helps,
J
Hello,
I think you can back up that decision with your trace exercise showing just validated ingredients are mixed to manufacture your finished product, since you have your purity certificates from your suppliers, just make sure your trace exercise makes sense. And agree with JaredD on the metals part, as long as you keep your metal detection verification and metal detector third party calibration certificates you'll be good in front of an auditor. Make sure that whatever you are using to verify the device's calibration is a certified item (ball, plate, etc.). Some magnets along the packing line would really help as well.
I hope it helps!
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?
Hi AMFD,
Unfortunately yr OP contains limited quantitative data regarding current sampling procedure, its objective(s), and the performance of current sampling program.
This rather limits the ability to make meaningful suggestions as to whether reduction of W XYZ is feasible.