Certificate of analysis: difference between revisions

Diff·revision 12 → 13·22:18, 9 Dec 2024

Difference between revision 12 and revision 13 of Certificate of analysis. 1 line changed; the page grew by 212 bytes.

Revision 12 — 18:25, 30 Nov 2024 PurityClaimPia (talk) add the point that reports reaching this wiki are not a sample of anything 5,485 bytes ±0	Revision 13 — 22:18, 9 Dec 2024 SecondarySrc_Seb (talk) state the method the reporting service uses, since it is not the only one available 5,697 bytes +212
8	\| Scope = One named lot	8	\| Scope = One named lot
9	}}	9	}}
+		10	{{hatnote\|This article is about the document. For results obtained by a laboratory unconnected with the supplier, see [[Third-party testing]]; for the sampling problem that limits both, see [[Blind sampling]].}}
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11	A '''certificate of analysis''' is a document issued with a consignment of material, reporting the results of specified tests carried out on a specified [[Batch number\|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 [[Lot traceability\|batch record]].{{r\|usp1503}} Outside that framework — which is where all material labelled [[Research use only\|for research use only]] sits — no obligation to issue one exists, no format is prescribed, and no authority audits what is written on it.	12	A '''certificate of analysis''' is a document issued with a consignment of material, reporting the results of specified tests carried out on a specified [[Batch number\|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 [[Lot traceability\|batch record]].{{r\|usp1503}} Outside that framework — which is where all material labelled [[Research use only\|for research use only]] sits — no obligation to issue one exists, no format is prescribed, and no authority audits what is written on it.