Beyond-use date: difference between revisions
Diff·revision 5 → 6·01:58, 28 Oct 2024
Difference between revision 5 and revision 6 of Beyond-use date. 12 lines changed; the page grew by 1,039 bytes.
| Revision 5 — 06:28, 23 Oct 2024 LedeLeander (talk) add PMID 3,225 bytes +975 | Revision 6 — 01:58, 28 Oct 2024 EndotoxinEd (talk) attribute claim in-text 4,264 bytes +1,039 | ||
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| 11 | The distinction is one of evidence rather than of vocabulary. An expiration date rests on long-term, intermediate and accelerated stability studies conducted under the conditions specified in ICH Q1A(R2), analysed statistically, and submitted to a regulator; it is a claim about the specific product in the specific container. A beyond-use date generally rests on a table of conservative defaults chosen to be safe across a wide range of preparations, and it is a claim about a class of preparations rather than about the one in hand. The two are therefore not comparable quantities, and a short beyond-use date does not imply a preparation degrades quickly.{{r|ich_q1a,usp797}} | 11 | The distinction is one of evidence rather than of vocabulary. An expiration date rests on long-term, intermediate and accelerated stability studies conducted under the conditions specified in ICH Q1A(R2), analysed statistically, and submitted to a regulator; it is a claim about the specific product in the specific container. A beyond-use date generally rests on a table of conservative defaults chosen to be safe across a wide range of preparations, and it is a claim about a class of preparations rather than about the one in hand. The two are therefore not comparable quantities, and a short beyond-use date does not imply a preparation degrades quickly.{{r|ich_q1a,usp797}} |
| 12 | 12 | ||
| + | 13 | Beyond-use dates in sterile compounding are limited principally by microbiological risk rather than by chemical degradation. The default periods in USP <797> are graduated by how the preparation was made, by whether sterility testing was performed and passed, and by storage temperature — not by the chemistry of the active substance. Chemical stability is a separate constraint, and where it is shorter it governs.{{r|usp797}} | |
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| 13 | == Definition and contrast with the expiration date == | 15 | == Definition and contrast with the expiration date == |
| 14 | An expiration date is the output of a defined regulatory process. Under ICH Q1A(R2), a manufacturer conducts long-term studies at the intended storage condition, intermediate studies where required, and accelerated studies at elevated temperature and humidity, on at least three primary batches in the container closure system intended for marketing. The results are evaluated — under ICH Q1E — to establish a retest period or shelf life, and the date is stated on the label. It applies to the unopened product stored as labelled.{{r|ich_q1a}} | 16 | An expiration date is the output of a defined regulatory process. Under ICH Q1A(R2), a manufacturer conducts long-term studies at the intended storage condition, intermediate studies where required, and accelerated studies at elevated temperature and humidity, on at least three primary batches in the container closure system intended for marketing. The results are evaluated — under ICH Q1E — to establish a retest period or shelf life, and the date is stated on the label. It applies to the unopened product stored as labelled.{{r|ich_q1a}} |
| 15 | 17 | ||
| 16 | A beyond-use date has none of that apparatus behind it. It applies to a preparation that the manufacturer's stability programme never examined: a container that has been opened, a solution that has been diluted, a lyophilised solid that has been reconstituted, or a preparation compounded from components. The chemistry may be identical; the container's history is not. | 18 | A beyond-use date has none of that apparatus behind it. It applies to a preparation that the manufacturer's stability programme never examined: a container that has been opened, a solution that has been diluted, a lyophilised solid that has been reconstituted, or a preparation compounded from components. The chemistry may be identical; the container's history is not. |
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| + | 20 | |+ Two kinds of date | |
| + | 21 | | !Property | Expiration date | Beyond-use date | | |
| + | 22 | |---|---|---| | |
| + | 23 | | Assigned by | Manufacturer | Compounder or dispenser | | |
| + | 24 | | Evidence base | Product-specific stability programme | Compendial default table, or preparation-specific testing | | |
| + | 25 | | Applies to | Unopened product, stored as labelled | Compounded or opened preparation | | |
| + | 26 | | Principal limiting factor | Chemical and physical degradation | Microbiological risk, then chemical stability | | |
| + | 27 | | Regulatory status | Submitted and approved | Assigned under a compendial standard | | |
| + | 28 | | Typical magnitude | 12–60 months | Hours to 180 days | | |
| 17 | 29 | ||
| 18 | == References == | 30 | == References == |