Lot traceability: difference between revisions
Diff·revision 3 → 4·09:00, 7 Aug 2024
Difference between revision 3 and revision 4 of Lot traceability. 5 lines changed; the page grew by 615 bytes.
| Revision 3 — 15:58, 25 Jul 2024 NPOV_Nadia (talk) correct the description of how lot identifiers are assigned 1,389 bytes ±0 | Revision 4 — 09:00, 7 Aug 2024 DMF_Dermot (talk) add the laboratory accreditation status, or say plainly that it is not stated 2,004 bytes +615 | ||
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| 10 | The link is carried by the [[Batch number|batch number]] and is only as strong as the weakest transfer in the chain. Every point at which material changes container, changes hands, or is combined with other material is a point at which the link can be preserved by record-keeping or lost by its absence.{{r|usp1503}} | 10 | The link is carried by the [[Batch number|batch number]] and is only as strong as the weakest transfer in the chain. Every point at which material changes container, changes hands, or is combined with other material is a point at which the link can be preserved by record-keeping or lost by its absence.{{r|usp1503}} |
| 11 | 11 | ||
| + | 12 | == What a lot is == | |
| + | 13 | A lot, or batch, is a quantity of material produced in a single process run under conditions intended to be uniform throughout. Uniformity is the point: it is the assumption that licenses extending a determination made on a sample to the whole quantity.{{r|iso9001}} | |
| + | 14 | ||
| + | 15 | The assumption is not automatic. A synthesis run purified in several chromatographic fractions may be homogenised into one lot or held as several; a lot filled over a long period may not be uniform in fill mass; and a "lot" assembled by combining material from separate runs is a lot by declaration rather than by production. | |
| + | 16 | ||
| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |