Lot traceability: difference between revisions
Diff·revision 5 → 6·17:17, 28 Aug 2024
Difference between revision 5 and revision 6 of Lot traceability. 2 lines changed; the page grew by 172 bytes.
| Revision 5 — 14:43, 18 Aug 2024 EndotoxinEd (talk) split overlong sentence 2,004 bytes ±0 | Revision 6 — 17:17, 28 Aug 2024 PanelPlannerPam (talk) add short description 2,176 bytes +172 | ||
|---|---|---|---|
| 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 | Traceability is a documentary property, not an analytical one. No amount of testing on a vial establishes which lot it came from; that is established, or not, by records. | |
| + | 13 | ||
| 12 | == What a lot is == | 14 | == 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}} | 15 | 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}} |