Test method documentation and details
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
Depending on what external lab you're using: if it doesn't have accreditation (not sure, how it's in US, in Canada it's SCC accreditation for compliance to ISO 17025), you'll definitely need a validation, however for the accredited lab I think filing that info would be redundant as those labs are using official methods for micro testing of foods approved by Ministry of Health.
If your lab is certified, they should be performing tests to referenced standards for the industry. They might publish this data on their website, or they might have to provide it to you in writing upon request.
Example here from FSNS labs discussing their internal reference numbers for various tests, showing which reference methods they're testing to (AOAC, FDA-BAM, USDA MLG, etc.): 1698-08 (fsns.com)
In India, it is mandatory to mention the testing method reference in the test report. If the testing method is In-house, then they need to share the method with the client mentioning the method of sample preparation, chemicals and reagents used for testing, instruments used etc. It is mandatory that the lab should be NABL accredited.