Certificate of analysis (revision 3)
Old revision·02:08, 26 Aug 2024·ChainCustodyChad
| Certificate of analysis | |
|---|---|
| Topic infobox · conventions |
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]
References
- ^ United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Describes the determinations that together characterise a synthetic peptide, and why purity alone does not.
- ^ ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories. International Organization for Standardization. The standard against which a testing laboratory's competence is assessed; self-description is not assessment against it.