Temperature excursion: difference between revisions
Diff·revision 55 → 56·18:52, 25 Jan 2026
Difference between revision 55 and revision 56 of Temperature excursion. 2 lines changed; the page grew by 61 bytes.
| Revision 55 — 11:34, 18 Jan 2026 ResinRhoswen (talk) update infobox 23,956 bytes +309 | Revision 56 — 18:52, 25 Jan 2026 CrudePeptidePearl (talk) tag [citation needed] 24,017 bytes +61 | ||
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| 142 | Two limitations are structural. Without a pre-excursion result for the same lot, a purity figure establishes only the current state, not a change; the retained sample is therefore the critical asset, and its absence is what most often makes a post-hoc assessment impossible. And a method's limit of detection sets a floor below which no statement can be made: an assay resolving 0.1% of a degradation product cannot demonstrate the absence of 0.05%, and a report of no detected change means no change above that floor rather than no change.{{r|ich_q1a}} | 142 | Two limitations are structural. Without a pre-excursion result for the same lot, a purity figure establishes only the current state, not a change; the retained sample is therefore the critical asset, and its absence is what most often makes a post-hoc assessment impossible. And a method's limit of detection sets a floor below which no statement can be made: an assay resolving 0.1% of a degradation product cannot demonstrate the absence of 0.05%, and a report of no detected change means no change above that floor rather than no change.{{r|ich_q1a}} |
| 143 | 143 | ||
| + | 144 | {{seealso|Analytical method validation|Limit of detection}} | |
| + | 145 | ||
| 144 | == Evidence quality outside regulated distribution == | 146 | == Evidence quality outside regulated distribution == |
| 145 | Where material is distributed without a stability programme, records or retained samples, the assessment machinery described above has no inputs. What remains is inference from general chemistry and observation by recipients, and the two are of very different value. | 147 | Where material is distributed without a stability programme, records or retained samples, the assessment machinery described above has no inputs. What remains is inference from general chemistry and observation by recipients, and the two are of very different value. |