COA (Certificate of Analysis) - What information should they include?

B

belemsanchez

#1
:bonk:Please, I'm a little bit lost about what is the information included in a COA of one IVD medical device. One Korean customer request to me more information to include in our coagulation COA, like CV value, deviation and coeficient of correaltion, precision, accuaracy, linearity and check with another company's controls/ calibrators at least 3 lots diferents.

anyone knows if there is any standard or guide about COA?

Thanks a lot
 
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#3
From your description (coefficient of correlation, precision, accuracy, linearity, comparison with another lab's results) it seems that your customer is requiring a method validation report rather than a regular CoA. I haven't done tests of medical devices for 10 years now, so I may not be updated on standard requirements, but usually (but not always, it depends on current practice in your niche market) the only statistical quantity that sometimes could be required in a CoA is a measurement uncertainty estimate. A good read about validation is ICH's "Validation of Analytical Procedures" (I wasn't allowed to provide the link here, but you can easily Google it.)
 
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