Lot traceability: difference between revisions
Diff·revision 11 → 12·00:29, 3 Dec 2024
Difference between revision 11 and revision 12 of Lot traceability. 12 lines changed; the page grew by 848 bytes.
| Revision 11 — 02:03, 16 Nov 2024 Chromatokid (talk) fix the anchor on an internal link 2,794 bytes ±0 | Revision 12 — 00:29, 3 Dec 2024 VerifyVesna (talk) state what the certificate actually carries, field by field 3,642 bytes +848 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = Lot traceability | 2 | | name = Lot traceability |
| + | 3 | | subtitle = Quality systems | |
| 3 | | image = supply-map.svg | 4 | | image = supply-map.svg |
| 4 | | caption = Each transfer either preserves the link between vial and record, or breaks it. | 5 | | caption = Each transfer either preserves the link between vial and record, or breaks it. |
| ⋮ | ⋮ | ||
| 20 | 21 | ||
| 21 | Because the definition is procedural rather than physical, the meaningful question about a lot number is what procedure assigned it. A number that identifies a synthesis campaign, a purification pool and a fill run supports a different inference from one assigned at the point of packing.{{r|ich_q7}} | 22 | Because the definition is procedural rather than physical, the meaningful question about a lot number is what procedure assigned it. A number that identifies a synthesis campaign, a purification pool and a fill run supports a different inference from one assigned at the point of packing.{{r|ich_q7}} |
| + | 23 | ||
| + | 24 | == Where the chain breaks == | |
| + | 25 | | Transfer | Link preserved by | Failure mode | | |
| + | 26 | |---|---|---| | |
| + | 27 | | Bulk to fill line | Fill record naming the bulk lot | Fill record not retained | | |
| + | 28 | | Fill to labelling | Label carrying the lot | Generic label without lot | | |
| + | 29 | | Supplier to distributor | Shipping record naming lots | Consolidated shipment, no lot detail | | |
| + | 30 | | Distributor to buyer | Invoice or packing list | Lot omitted from paperwork | | |
| + | 31 | | Any [[Repackaging]] | New record referencing the old lot | New lot number with no back-reference | | |
| + | 32 | ||
| + | 33 | The last row is the most consequential. [[Repackaging|Repackaging]] into new containers with a newly assigned identifier and no back-reference severs the chain completely, and the resulting vial cannot be associated with any certificate however genuine that certificate is.{{r|usp1503}} | |
| 22 | 34 | ||
| 23 | == References == | 35 | == References == |