[mturinaiwe1]

Hello everyone,

When any testing (e.g pesticide residues, heavy metals, etc) for say a drug substance is outsourced to a third party laboratory, is it a regulatory requirement to include the test results on the drug substance's Certificate of analysis (COA), or can they be provided as a separate document?

[TriVision]

That's more of a legality question than a chemistry one, however, I believe that it is standard (not required, mind you) that test results for certain substances considered more "dangerous" are attached directly with the COA, or attached with a separate document. If you simply got a COA without a separate document containing the results of the test it doesn't help prove anything, especially in a legal setting where a warrant (requiring legal cause)might be needed to test or search any further.

In other words: Not attaching a document containing exact test results with the COA is considered a d*ck move.