Active pharmaceutical ingredient: difference between revisions
Diff·revision 4 → 5·13:26, 28 Dec 2024
Difference between revision 4 and revision 5 of Active pharmaceutical ingredient. 3 lines changed; the page grew by 404 bytes.
| Revision 4 — 12:31, 13 Dec 2024 GreyMarketGreer (talk) rm the advice on importation; the article describes the position and does not advise 1,752 bytes ±0 | Revision 5 — 13:26, 28 Dec 2024 Retention_Time_Rae (talk) clarify the difference between a marketing authorisation and a registration 2,156 bytes +404 | ||
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| 11 | That distinction determines which requirements apply. API manufacture is subject to [[Good manufacturing practice|GMP]] and to registration in many jurisdictions; the same chemistry performed for research supply is not.{{r|ich_q7}} | 11 | That distinction determines which requirements apply. API manufacture is subject to [[Good manufacturing practice|GMP]] and to registration in many jurisdictions; the same chemistry performed for research supply is not.{{r|ich_q7}} |
| 12 | 12 | ||
| + | 13 | The practical consequence is that "pharmaceutical grade" applied to a research chemical is not a defined term. Where it means anything, it means the supplier's own grade designation, and what it covers is whatever the accompanying specification says.{{r|usp1503}} | |
| + | 14 | ||
| 13 | == The regulatory frame == | 15 | == The regulatory frame == |
| 14 | Guidance for APIs covers the same ground as finished-product GMP, adapted to bulk substance: materials, process controls, validation, records, and the point in a process at which GMP begins to apply — which for a synthetic API is generally the introduction of the starting material into the process.{{r|ich_q7}} | 16 | Guidance for APIs covers the same ground as finished-product GMP, adapted to bulk substance: materials, process controls, validation, records, and the point in a process at which GMP begins to apply — which for a synthetic API is generally the introduction of the starting material into the process.{{r|ich_q7}} |
| ⋮ | ⋮ | ||
| 19 | {{reflist}} | 21 | {{reflist}} |
| 20 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 22 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| + | 23 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 21 | 24 | ||
| 22 | {{DEFAULTSORT:Active pharmaceutical ingredient}} | 25 | {{DEFAULTSORT:Active pharmaceutical ingredient}} |