Temperature excursion: difference between revisions
Diff·revision 44 → 45·21:08, 10 Nov 2025
Difference between revision 44 and revision 45 of Temperature excursion. 10 lines changed; the page grew by 1,146 bytes.
| Revision 44 — 14:59, 2 Nov 2025 PharmDrafts (talk) attribute range as a review estimate per talk 18,546 bytes +21 | Revision 45 — 21:08, 10 Nov 2025 ArchiveBot (talk) bot: normalise citation format 19,692 bytes +1,146 | ||
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| 116 | For lyophilised material the picture reverses. A dry cake has no ice to form and no interface to create, and freezing a sealed lyophilised vial is generally regarded as harmless — which is why frozen storage is the recommended long-term condition for dry peptide while being contraindicated for the same peptide in solution.{{r|ich_q1a}} | 116 | For lyophilised material the picture reverses. A dry cake has no ice to form and no interface to create, and freezing a sealed lyophilised vial is generally regarded as harmless — which is why frozen storage is the recommended long-term condition for dry peptide while being contraindicated for the same peptide in solution.{{r|ich_q1a}} |
| 117 | 117 | ||
| + | 118 | == Assessment and disposition == | |
| + | 119 | Disposition of a product after an excursion follows a defined sequence, and its output is a documented decision rather than a measurement. | |
| + | 120 | ||
| + | 121 | # The record is retrieved, its instrument's calibration status confirmed, and the profile reconstructed with custody points identified. | |
| + | 122 | # The exposure is characterised: maximum and minimum reached, duration outside the labelled range, mean kinetic temperature over the relevant period, and whether any threshold such as freezing was crossed. | |
| + | 123 | # The exposure is charged against the product's stability budget, cumulatively with any previous excursions recorded for that consignment. | |
| + | 124 | # The manufacturer's stability data are consulted, including accelerated and stress data, to establish whether the exposure lies within a range for which behaviour is known. | |
| + | 125 | # Where the exposure falls outside what the data support, confirmatory testing is performed on a sample, using methods capable of detecting the degradation expected. | |
| + | 126 | # A disposition is recorded: release unchanged, release with shortened dating, quarantine pending further data, or rejection.{{r|whotrs961,eugdp2013}} | |
| + | 127 | ||
| 118 | == References == | 128 | == References == |
| 119 | {{reflist}} | 129 | {{reflist}} |