Certificate of analysis (revision 2)

A certificate of analysis is a document issued with a consignment of material, reporting the results of specified tests carried out on a specified lot. In regulated pharmaceutical supply it is the record by which a quality unit releases material against a written specification, and it is retained as part of the batch record.^[1] Outside that framework — which is where all material labelled for research use only sits — no obligation to issue one exists, no format is prescribed, and no authority audits what is written on it.

The document's evidential standing follows from who issues it. A certificate is a claim by its issuer about material it is selling. That is not a criticism: a claim made in writing, against a named lot, by an identifiable party, is a substantially stronger thing than no claim at all, and it is checkable in ways a verbal assurance is not. It is simply not the same as an independent measurement, and the two are frequently conflated.^[2]