Repackaging: difference between revisions
Diff·revision 5 → 6·11:04, 15 Nov 2024
Difference between revision 5 and revision 6 of Repackaging. 4 lines changed; the page grew by 444 bytes.
| Revision 5 — 20:41, 2 Nov 2024 OralSemaOswin (talk) expand §Why the record is the whole thing 2,460 bytes +397 | Revision 6 — 11:04, 15 Nov 2024 FreightFenna (talk) add the figure for the lyophilisation cycle and caption it 2,904 bytes +444 | ||
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| 10 | A repackager who assigns a new [[Batch number|batch number]] without recording the original one has severed the link between the container and every determination ever made on the material. The resulting vial cannot be associated with any [[Certificate of analysis|certificate]], however genuine that certificate is.{{r|iso9001}} | 10 | A repackager who assigns a new [[Batch number|batch number]] without recording the original one has severed the link between the container and every determination ever made on the material. The resulting vial cannot be associated with any [[Certificate of analysis|certificate]], however genuine that certificate is.{{r|iso9001}} |
| 11 | 11 | ||
| + | 12 | Repackaging also introduces its own risks. Material is exposed to the environment during transfer, containers and closures may differ from those the stability data were generated in, and any new dating is a fresh assertion rather than an inherited one.{{r|usp1503}} | |
| + | 13 | ||
| 12 | == Why the record is the whole thing == | 14 | == Why the record is the whole thing == |
| 13 | Nothing about repackaged material is detectable by analysis. A repackaged peptide is the same molecule, and a determination on it returns the same numbers; what has changed is what is known about where it came from.{{r|iso9001}} | 15 | Nothing about repackaged material is detectable by analysis. A repackaged peptide is the same molecule, and a determination on it returns the same numbers; what has changed is what is known about where it came from.{{r|iso9001}} |
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| 28 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 30 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 29 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2.</ref> | 31 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2.</ref> |
| + | 32 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 30 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 33 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| 31 | 34 | ||
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| 33 | [[Category:Supply chain integrity]] | 36 | [[Category:Supply chain integrity]] |
| 34 | [[Category:Traceability]] | 37 | [[Category:Traceability]] |
| + | 38 | [[Category:Manufacturing and supply]] | |
| 35 | 39 |