Lot traceability: difference between revisions
Diff·revision 7 → 8·03:13, 23 Sep 2024
Difference between revision 7 and revision 8 of Lot traceability. 3 lines changed; the page grew by 456 bytes.
| Revision 7 — 20:53, 15 Sep 2024 OralSemaOswin (talk) rm a duplicated category 2,212 bytes +36 | Revision 8 — 03:13, 23 Sep 2024 SarcopeniaSefa (talk) add the citation for the blind-sampling discussion 2,668 bytes +456 | ||
|---|---|---|---|
| 17 | The assumption is not automatic. A synthesis run purified in several chromatographic fractions may be homogenised into one lot or held as several; a lot filled over a long period may not be uniform in fill mass; and a "lot" assembled by combining material from separate runs is a lot by declaration rather than by production. | 17 | The assumption is not automatic. A synthesis run purified in several chromatographic fractions may be homogenised into one lot or held as several; a lot filled over a long period may not be uniform in fill mass; and a "lot" assembled by combining material from separate runs is a lot by declaration rather than by production. |
| 18 | 18 | ||
| + | 19 | Because the definition is procedural rather than physical, the meaningful question about a lot number is what procedure assigned it. A number that identifies a synthesis campaign, a purification pool and a fill run supports a different inference from one assigned at the point of packing.{{r|ich_q7}} | |
| + | 20 | ||
| 19 | == References == | 21 | == References == |
| 20 | {{reflist}} | 22 | {{reflist}} |
| 21 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2 (identification and traceability).</ref> | 23 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2 (identification and traceability).</ref> |
| 22 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 24 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 25 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 23 | 26 | ||
| 24 | {{DEFAULTSORT:Lot traceability}} | 27 | {{DEFAULTSORT:Lot traceability}} |