Certificate of analysis: difference between revisions
Diff·revision 3 → 4·16:49, 5 Sep 2024
Difference between revision 3 and revision 4 of Certificate of analysis. 14 lines changed; the page grew by 1,014 bytes.
| Revision 3 — 02:08, 26 Aug 2024 ChainCustodyChad (talk) split §What a report shows from §What it does not 1,858 bytes ±0 | Revision 4 — 16:49, 5 Sep 2024 ArchiveBot (talk) bot: normalise citation format 2,872 bytes +1,014 | ||
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| 7 | 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.{{r|iso17025}} | 7 | 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.{{r|iso17025}} |
| 8 | 8 | ||
| + | 9 | == Fields and what each establishes == | |
| + | 10 | 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. | |
| + | 11 | ||
| + | 12 | | Field | Answers | Comment | | |
| + | 13 | |---|---|---| | |
| + | 14 | | Product identity | What the material is claimed to be | Should give a name a reader can look up, not a catalogue code alone | | |
| + | 15 | | Lot identifier | Which material this document describes | Must match the vial label; see [[Lot traceability]] | | |
| + | 16 | | Test performed | What was measured | "Purity" alone is not a test; a method makes it one | | |
| + | 17 | | Method | How it was measured | Without this, two results cannot be compared | | |
| + | 18 | | Specification | What the result was measured against | A result with no specification is a number, not a release decision | | |
| + | 19 | | Result | What was found | Should carry its units and its significant figures honestly | | |
| + | 20 | | Release date and signatory | When and by whom the lot was released | A signature records release, not verification | | |
| + | 21 | ||
| 9 | == References == | 22 | == References == |
| 10 | {{reflist}} | 23 | {{reflist}} |
| ⋮ | ⋮ | ||
| 15 | [[Category:Certificates of analysis]] | 28 | [[Category:Certificates of analysis]] |
| 16 | [[Category:Testing methodology]] | 29 | [[Category:Testing methodology]] |
| + | 30 | [[Category:Traceability]] | |
| 17 | 31 |