Hello, what details should we document in the test methods that our third-party lab is performing? We document the test method on our own form/template.
We have at least one that has only the test method code/reference (e.g., "Test method XYZ123") and has no details of how to perform it; it is a strength testing method for lycopene. It seems to me this is inadequate and we should have at least the sample prep details and the details of the instrumental analysis. The only reason I could think of why we wouldn't have that information is if the test method was proprietary, but it shouldn't be, as we need to know that the sample prep and instrumental analysis is being performed in a scientifically valid way. Is this correct?
We are in the United States and manufacture dietary supplements under 21 CFR Part 111 and 117, and we have SQF and NSF GMP certifications.
Thank you,
Matthew