Temperature excursion: difference between revisions
Diff·revision 48 → 49·14:34, 6 Dec 2025
Difference between revision 48 and revision 49 of Temperature excursion. 5 lines changed; the page grew by 585 bytes.
| Revision 48 — 21:27, 30 Nov 2025 SigFigSindri (talk) convert list to prose 19,692 bytes ±0 | Revision 49 — 14:34, 6 Dec 2025 HOMA_Hettie (talk) split overlong sentence 20,277 bytes +585 | ||
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| 126 | # A disposition is recorded: release unchanged, release with shortened dating, quarantine pending further data, or rejection.{{r|whotrs961,eugdp2013}} | 126 | # A disposition is recorded: release unchanged, release with shortened dating, quarantine pending further data, or rejection.{{r|whotrs961,eugdp2013}} |
| 127 | 127 | ||
| + | 128 | Two structural features of this sequence are worth noting. It is asymmetric in favour of rejection, because the burden is to show that quality is unaffected rather than to show that it is affected. And it depends at step 4 on data that exist only for products with a stability programme, which is why the sequence cannot be applied outside regulated distribution however carefully the temperature was recorded.{{r|ich_q1a}} | |
| + | 129 | ||
| 128 | == References == | 130 | == References == |
| 129 | {{reflist}} | 131 | {{reflist}} |
| ⋮ | ⋮ | ||
| 148 | * Seevers RH, Hofer J, Harber P, Ulrich DA, Bishara R. "The use of mean kinetic temperature (MKT) in the handling, storage and distribution of temperature-sensitive pharmaceuticals." ''American Pharmaceutical Review'' (2009). | 150 | * Seevers RH, Hofer J, Harber P, Ulrich DA, Bishara R. "The use of mean kinetic temperature (MKT) in the handling, storage and distribution of temperature-sensitive pharmaceuticals." ''American Pharmaceutical Review'' (2009). |
| 149 | * Parenteral Drug Association. ''Technical Report No. 39: Guidance for Temperature-Controlled Medicinal Products'', revised edition. | 151 | * Parenteral Drug Association. ''Technical Report No. 39: Guidance for Temperature-Controlled Medicinal Products'', revised edition. |
| + | 152 | ||
| + | 153 | == External links == | |
| + | 154 | * [https://www.ich.org/ ICH Q1A(R2)] — Stability testing guideline; freely available and the basis of every labelled storage statement. | |
| 150 | 155 | ||
| 151 | == See also == | 156 | == See also == |