Grey market: difference between revisions
Diff·revision 4 → 5·21:42, 15 Jan 2025
Difference between revision 4 and revision 5 of Grey market. 4 lines changed; the page grew by 445 bytes.
| Revision 4 — 07:29, 31 Dec 2024 PanelPlannerPam (talk) serial comma per PP:MOS 2,131 bytes +331 | Revision 5 — 21:42, 15 Jan 2025 RfC_Rasmus (talk) add the shelf temperature and the primary drying step to the cycle description 2,576 bytes +445 | ||
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| 10 | For research chemicals the term is used loosely, since much of the market operates without authorised channels in the first place. It is most meaningful where a licensed product exists and material is traded outside its distribution system, or where material intended for one use is diverted to another.{{r|ich_q7}} | 10 | For research chemicals the term is used loosely, since much of the market operates without authorised channels in the first place. It is most meaningful where a licensed product exists and material is traded outside its distribution system, or where material intended for one use is diverted to another.{{r|ich_q7}} |
| 11 | 11 | ||
| + | 12 | The substantive issue is provenance and handling. A genuine article that has passed through an unrecorded chain has an unknown storage history, and no analysis performed afterwards can distinguish manufacture from handling as the cause of what it finds.{{r|usp1503}} | |
| + | 13 | ||
| 12 | == How goods leave authorised channels == | 14 | == How goods leave authorised channels == |
| 13 | Diversion occurs at several points: material sold for one purpose and resold for another, quantities in excess of a customer's use resold onward, or stock from one territory sold into another where prices differ.{{r|ich_q7}} | 15 | Diversion occurs at several points: material sold for one purpose and resold for another, quantities in excess of a customer's use resold onward, or stock from one territory sold into another where prices differ.{{r|ich_q7}} |
| ⋮ | ⋮ | ||
| 22 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 24 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 23 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 25 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| + | 26 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 24 | 27 | ||
| 25 | {{DEFAULTSORT:Grey market}} | 28 | {{DEFAULTSORT:Grey market}} |
| 26 | [[Category:Supply chain integrity]] | 29 | [[Category:Supply chain integrity]] |
| 27 | [[Category:Regulation and law]] | 30 | [[Category:Regulation and law]] |
| + | 31 | [[Category:Manufacturing and supply]] | |
| 28 | 32 |