Repackaging: difference between revisions
Diff·revision 11 → 12·20:48, 8 Feb 2025
Difference between revision 11 and revision 12 of Repackaging. 8 lines changed; the page grew by 340 bytes.
| Revision 11 — 13:36, 24 Jan 2025 CouplingCillian (talk) state the difference between a validated shipper and an insulated box 3,597 bytes +39 | Revision 12 — 20:48, 8 Feb 2025 FreightFenna (talk) sentence case in headings per PP:MOS 3,937 bytes +340 | ||
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| 32 | Container and closure differ too. Stability data are generated in a specific container-closure system, and transferring material to a different one invalidates the direct applicability of those data — a technical point rather than a legal one for material outside regulated supply. | 32 | Container and closure differ too. Stability data are generated in a specific container-closure system, and transferring material to a different one invalidates the direct applicability of those data — a technical point rather than a legal one for material outside regulated supply. |
| 33 | 33 | ||
| + | 34 | Where the original container was stoppered under vacuum or inert gas, that headspace is lost on opening and is not reproduced unless the repackaging operation restores it. See [[Vial filling and stoppering]].{{r|ich_q7}} | |
| + | 35 | ||
| 34 | == References == | 36 | == References == |
| 35 | {{reflist}} | 37 | {{reflist}} |
| ⋮ | ⋮ | ||
| 38 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 40 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 39 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 41 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 42 | ||
| + | 43 | == See also == | |
| + | 44 | * [[Lot traceability]] | |
| + | 45 | * [[Batch number]] | |
| + | 46 | * [[Counterfeit peptide]] | |
| + | 47 | * [[Vial filling and stoppering]] | |
| 40 | 48 | ||
| 41 | {{DEFAULTSORT:Repackaging}} | 49 | {{DEFAULTSORT:Repackaging}} |