Certificate of analysis (revision 6)
Old revision·04:13, 22 Sep 2024·BatchNumberBede
| 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]
Fields and what each establishes
[edit]A certificate that is useful for anything carries at least seven fields. Each of them answers a question that cannot be answered from any of the others.
| Field | Answers | Comment |
|---|---|---|
| Product identity | What the material is claimed to be | Should give a name a reader can look up, not a catalogue code alone |
| Lot identifier | Which material this document describes | Must match the vial label; see Lot traceability |
| Test performed | What was measured | "Purity" alone is not a test; a method makes it one |
| Method | How it was measured | Without this, two results cannot be compared |
| Specification | What the result was measured against | A result with no specification is a number, not a release decision |
| Result | What was found | Should carry its units and its significant figures honestly |
| Release date and signatory | When and by whom the lot was released | A signature records release, not verification |
A specification is a list of tests, the analytical procedures referenced by them, and the acceptance criteria applied to the results, so a figure reported with no specification against it has not been the subject of a release decision at all.[3]
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.
- ^ International Council for Harmonisation, Q6A: Specifications — Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Defines a specification as a list of tests, references to analytical procedures and acceptance criteria; a result reported without one is not a release decision.