Batch number: difference between revisions
Diff·revision 1 → 2·09:01, 8 Aug 2024
Difference between revision 1 and revision 2 of Batch number. 6 lines changed; the page grew by 811 bytes.
| Revision 1 — 16:28, 7 Aug 2024 VerifyVesna (talk) start article on the testing subject 1,182 bytes +1,182 | Revision 2 — 09:01, 8 Aug 2024 TelehealthTruus (talk) give the fields a compendially-complete certificate would carry 1,993 bytes +811 | ||
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| 10 | The number itself carries no information about quality. Its function is referential: it allows a determination recorded against a lot to be applied to a container, and it allows a container to be traced to production records. A batch number with no records behind it is a string of characters.{{r|usp1503}} | 10 | The number itself carries no information about quality. Its function is referential: it allows a determination recorded against a lot to be applied to a container, and it allows a container to be traced to production records. A batch number with no records behind it is a string of characters.{{r|usp1503}} |
| 11 | 11 | ||
| + | 12 | == Assignment == | |
| + | 13 | Numbers may be assigned at several stages, and the stage determines what the number identifies. A number assigned at synthesis identifies a production campaign; at purification, a pool; at fill, a filling run; at packing, a shipment. These are not equivalent, and the same physical material can carry different identifiers under different schemes.{{r|ich_q7}} | |
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| + | 15 | Formats vary and no convention is universal. Common patterns encode a date, a product code and a sequence; others are opaque serial numbers. An encoded date is convenient but is not verification: a date embedded in an identifier is an assertion like any other field on a label. | |
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| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |
| 14 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2.</ref> | 19 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements'', clause 8.5.2.</ref> |
| 15 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 20 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 21 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 16 | 22 | ||
| 17 | {{DEFAULTSORT:Batch number}} | 23 | {{DEFAULTSORT:Batch number}} |