Contract development and manufacturing organisation: difference between revisions
Diff·revision 5 → 6·01:30, 18 Dec 2024
Difference between revision 5 and revision 6 of Contract development and manufacturing organisation. 3 lines changed; the page grew by 325 bytes.
| Revision 5 — 07:32, 9 Dec 2024 FmocFrancis (talk) correct the transit-time figure — the source gives a median, not a maximum 2,521 bytes +269 | Revision 6 — 01:30, 18 Dec 2024 CrossRefCleve (talk) state the difference between a validated shipper and an insulated box 2,846 bytes +325 | ||
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| 10 | Its consequence for anyone reading supplier documentation is that the organisation named on a catalogue is not necessarily the organisation that made the material. A brand may be a manufacturer, a distributor of its own contract-manufactured material, or a reseller of another's — and the documentation may not distinguish these.{{r|iso9001}} | 10 | Its consequence for anyone reading supplier documentation is that the organisation named on a catalogue is not necessarily the organisation that made the material. A brand may be a manufacturer, a distributor of its own contract-manufactured material, or a reseller of another's — and the documentation may not distinguish these.{{r|iso9001}} |
| 11 | 11 | ||
| + | 12 | The distinction matters for [[Lot traceability|traceability]] rather than for quality as such. Contract-manufactured material with an intact record chain is fully traceable; the failure mode is a chain broken at the transfer, which is a records question. See [[Repackaging]].{{r|ich_q7}} | |
| + | 13 | ||
| 12 | == What a CDMO does == | 14 | == What a CDMO does == |
| 13 | Services span process development, analytical method development, scale-up, manufacture and, in some cases, fill-finish. A customer may buy any subset: a fully developed process transferred in, or a molecule and a target specification with everything else contracted out.{{r|ich_q7}} | 15 | Services span process development, analytical method development, scale-up, manufacture and, in some cases, fill-finish. A customer may buy any subset: a fully developed process transferred in, or a molecule and a target specification with everything else contracted out.{{r|ich_q7}} |
| ⋮ | ⋮ | ||
| 26 | [[Category:Contract manufacturers]] | 28 | [[Category:Contract manufacturers]] |
| 27 | [[Category:Manufacturing and supply]] | 29 | [[Category:Manufacturing and supply]] |
| + | 30 | [[Category:Supply chain integrity]] | |
| 28 | 31 |