Active pharmaceutical ingredient: difference between revisions
Diff·revision 1 → 2·02:17, 29 Nov 2024
Difference between revision 1 and revision 2 of Active pharmaceutical ingredient. 5 lines changed; the page grew by 609 bytes.
| Revision 1 — 09:00, 25 Nov 2024 SyringeSybille (talk) start article on the regulatory position 1,143 bytes +1,143 | Revision 2 — 02:17, 29 Nov 2024 LabelLibby (talk) add the customs-detention point with its source 1,752 bytes +609 | ||
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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 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}} | |
| + | 15 | ||
| + | 16 | Registration mechanisms vary. A [[Drug master file|drug master file]] allows a manufacturer to submit confidential process detail to a regulator and to authorise a customer to reference it; other jurisdictions use certificates of suitability or direct registration. | |
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| 13 | == References == | 18 | == References == |
| 14 | {{reflist}} | 19 | {{reflist}} |