Peptide supply chain: difference between revisions
Diff·revision 5 → 6·20:24, 9 Nov 2024
Difference between revision 5 and revision 6 of Peptide supply chain. 5 lines changed; the page grew by 901 bytes.
| Revision 5 — 20:55, 31 Oct 2024 CaptionCzeslaw (talk) correct the eutectic temperature — source gives a range 2,638 bytes ±0 | Revision 6 — 20:24, 9 Nov 2024 CRP_Cormac (talk) expand §Handovers, and why they are where things go missing 3,539 bytes +901 | ||
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| 7 | Each operation has a characteristic failure mode, and the great majority of quality observations made downstream are attributable to one of them rather than to a general property of the material or the seller.{{r|gmp}} Knowing which stage produces which observation is what allows a purchaser to read a [[Certificate of analysis|certificate]] as evidence about something rather than as a number. | 7 | Each operation has a characteristic failure mode, and the great majority of quality observations made downstream are attributable to one of them rather than to a general property of the material or the seller.{{r|gmp}} Knowing which stage produces which observation is what allows a purchaser to read a [[Certificate of analysis|certificate]] as evidence about something rather than as a number. |
| 8 | 8 | ||
| + | 9 | The '''documentary''' shape of the chain matters as much as the physical one. A certificate is created once, at release, at the end of finishing. Everything that happens afterwards — freight, storage, the interval in a warehouse, any repackaging — happens after the document exists and is not described by it. Most of the gaps this wiki records at supplier level are gaps of that kind.{{r|reports}} | |
| + | 10 | ||
| 9 | == The stages and what each can go wrong at == | 11 | == The stages and what each can go wrong at == |
| 10 | | Stage | What happens | Characteristic failure mode | Visible in | | 12 | | Stage | What happens | Characteristic failure mode | Visible in | |
| ⋮ | ⋮ | ||
| 18 | | Freight and storage | Transport, customs, warehousing | [[Temperature excursion]]; undocumented storage interval | Nothing on the certificate | | 20 | | Freight and storage | Transport, customs, warehousing | [[Temperature excursion]]; undocumented storage interval | Nothing on the certificate | |
| 19 | 21 | ||
| + | 22 | The final row is the one with no entry in the last column, and that is the point of the table. Everything above it leaves a trace in a determination somebody performs. Freight and storage leave a trace only if a data logger travelled with the consignment, and one usually does not.{{r|reports}} | |
| + | 23 | ||
| 20 | == References == | 24 | == References == |
| 21 | {{reflist}} | 25 | {{reflist}} |
| 22 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | 26 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> |
| + | 27 | <ref name="reports">Purchaser-submitted reports and accompanying documentation held by PeptidePedia, 2024–2026, including descriptions of dispatch origin and packaging. A self-selected sample.</ref> | |
| 23 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. Sets out the stage-by-stage controls that unregulated supply is not obliged to operate.</ref> | 28 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. Sets out the stage-by-stage controls that unregulated supply is not obliged to operate.</ref> |
| 24 | 29 |