Comment from Pace Analytical Life Sciences, LLC
AnonymousSupportIndividual
Summary: The commenter suggests a structural change to the guidance to move a general reporting requirement out of the "Outlier Tests" subsection. They also request that the document include more specific guidance regarding the responsibilities of contract laboratories during investigations.
Section C.2 Outlier Tests contains a statement that 'In addition, when investigation by a contract laboratory does not determine an assignable cause, all test results should be reported to the customer on the certificate of analysis. This statement applies not only to outlier tests but also to all investigations performed by a contract laboratory in which no assignable cause is determined. The statement is applicable to reporting of results in general, thus it should be moved out of the Outlier subsection.
There are very few mentions of the responsibilities of contract laboratories. Please consider adding more guidance that is specific to investigations performed for contract laboratory testing.