Cold chain: difference between revisions
Diff·revision 24 → 25·23:25, 30 Sep 2024
Difference between revision 24 and revision 25 of Cold chain. 3 lines changed; the page grew by 544 bytes.
| Revision 24 — 20:52, 23 Sep 2024 Ref_Desk_Ron (talk) rv restoration of unsourced claim 10,269 bytes ±0 | Revision 25 — 23:25, 30 Sep 2024 CustomsClarke (talk) add hatnote 10,813 bytes +544 | ||
|---|---|---|---|
| 68 | The conventional expectation for a logger used in 2–8 °C distribution is an accuracy of ±0.5 °C across that range. This is an expectation drawn from qualification practice and from performance specifications for prequalified devices; it is not a requirement imposed by a general chapter, and articles asserting it as a standard have been corrected on this point.{{r|whotrs961,usp1118}} | 68 | The conventional expectation for a logger used in 2–8 °C distribution is an accuracy of ±0.5 °C across that range. This is an expectation drawn from qualification practice and from performance specifications for prequalified devices; it is not a requirement imposed by a general chapter, and articles asserting it as a standard have been corrected on this point.{{r|whotrs961,usp1118}} |
| 69 | 69 | ||
| + | 70 | Traceability of the record itself is a separate question from calibration of the sensor. A record that cannot be tied to a specific consignment, with the times of custody transfer identified, cannot be used to attribute an excursion to a stage of the chain, which is the purpose for which such records are chiefly wanted.{{r|eugdp2013}} | |
| + | 71 | ||
| 70 | == References == | 72 | == References == |
| 71 | {{reflist}} | 73 | {{reflist}} |
| ⋮ | ⋮ | ||
| 77 | <ref name="kartoglu2014">Kartoglu U, Milstien J. "Tools and approaches to ensure quality of vaccines throughout the cold chain." ''Expert Review of Vaccines'' 13(7):843–854 (2014).</ref> | 79 | <ref name="kartoglu2014">Kartoglu U, Milstien J. "Tools and approaches to ensure quality of vaccines throughout the cold chain." ''Expert Review of Vaccines'' 13(7):843–854 (2014).</ref> |
| 78 | <ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref> | 80 | <ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref> |
| + | 81 | <ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01). Official Journal of the European Union.</ref> | |
| 79 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | 82 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> |
| 80 | 83 |