Cold chain: difference between revisions
Diff·revision 36 → 37·00:24, 28 Jan 2026
Difference between revision 36 and revision 37 of Cold chain. 2 lines changed; the page grew by 70 bytes.
| Revision 36 — 21:08, 1 Jan 2026 Retention_Time_Rae (talk) clarify that the cake appearance is an indicator, not a specification 27,150 bytes ±0 | Revision 37 — 00:24, 28 Jan 2026 CDMO_Caradoc (talk) convert the storage conditions to a table 27,220 bytes +70 | ||
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| 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}} | 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 | 170 | ||
| + | 171 | {{seealso|Temperature excursion|Cold-chain freight|Beyond-use date}} | |
| + | 172 | ||
| 171 | == References == | 173 | == References == |
| 172 | {{reflist}} | 174 | {{reflist}} |