Lot traceability: difference between revisions
Diff·revision 20 → 21·01:47, 29 May 2025
Difference between revision 20 and revision 21 of Lot traceability. 6 lines changed; the page grew by 749 bytes.
| Revision 20 — 11:30, 6 May 2025 AttributeAnders (talk) add the note on how to request a batch record rather than a certificate 4,028 bytes +26 | Revision 21 — 01:47, 29 May 2025 OpenLabelOtto (talk) add the note that self-submitted reports are a self-selected sample 4,777 bytes +749 | ||
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| 35 | Consolidation is the second most consequential. Where a shipment draws several lots and the paperwork names one, every subsequent inference about the material is unsound, and this failure is invisible to the recipient. | 35 | Consolidation is the second most consequential. Where a shipment draws several lots and the paperwork names one, every subsequent inference about the material is unsound, and this failure is invisible to the recipient. |
| 36 | 36 | ||
| + | 37 | == What good traceability looks like from the outside == | |
| + | 38 | A purchaser can observe only a few things, and none of them proves traceability — they are the observable consequences of it. | |
| + | 39 | ||
| + | 40 | The lot identifier appears on the vial, on the certificate and on the shipping paperwork, and the three agree. The certificate is lot-specific rather than a product-level document reissued for every order. A request for a certificate covering a lot bought some time ago can be met from records rather than by reissuing a current document. Where a consignment contains more than one lot, the paperwork says so.{{r|reports}} | |
| + | 41 | ||
| 37 | == References == | 42 | == References == |
| 38 | {{reflist}} | 43 | {{reflist}} |
| 39 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2 (identification and traceability).</ref> | 44 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2 (identification and traceability).</ref> |
| 40 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 45 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 46 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 41 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 47 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 42 | 48 |