Cold chain: difference between revisions
Diff·revision 76 → 77·11:13, 5 Dec 2025
Difference between revision 76 and revision 77 of Cold chain. 2 lines changed; the page grew by 567 bytes.
| Revision 76 — 07:32, 26 Nov 2025 CategoryBot (talk) bot: repair redlinked category 26,583 bytes ±0 | Revision 77 — 11:13, 5 Dec 2025 ArchiveBot (talk) bot: sort category members 27,150 bytes +567 | ||
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| 167 | USP <1079> approaches the same ground from the compendial side, describing risks in storage and transport and mitigation strategies, and it is the chapter in which mean kinetic temperature and the treatment of excursions are elaborated for United States practice. USP <1118> covers the monitoring devices themselves.{{r|usp1079,usp1118}} | 167 | USP <1079> approaches the same ground from the compendial side, describing risks in storage and transport and mitigation strategies, and it is the chapter in which mean kinetic temperature and the treatment of excursions are elaborated for United States practice. USP <1118> covers the monitoring devices themselves.{{r|usp1079,usp1118}} |
| 168 | 168 | ||
| + | 169 | The stability data that make any of this meaningful come from the ICH stability programme. A labelled storage statement is an inference from long-term, intermediate and accelerated stability studies conducted under defined conditions, and the permitted in-use periods and excursion allowances quoted on labels are supported by those studies rather than by general principle. A product with no such programme has a storage recommendation and not a storage specification, which is the fundamental asymmetry between regulated and unregulated distribution.{{r|ich_q1a}} | |
| + | 170 | ||
| 169 | == References == | 171 | == References == |
| 170 | {{reflist}} | 172 | {{reflist}} |