Active pharmaceutical ingredient: difference between revisions
Diff·revision 5 → 6·23:03, 5 Jan 2025
Difference between revision 5 and revision 6 of Active pharmaceutical ingredient. 5 lines changed; the page grew by 676 bytes.
| 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 | Revision 6 — 23:03, 5 Jan 2025 ImportRecordIna (talk) add the citation for the regulatory action 2,832 bytes +676 | ||
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| 18 | 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. | 18 | 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. |
| 19 | 19 | ||
| + | 20 | None of this applies to a research chemical. A supplier may nonetheless hold registrations for other product lines, and such a registration is a checkable claim in the sense described at [[Good manufacturing practice]] — with a registrant, a number and a scope.{{r|iso9001}} Documents submitted to this wiki that assert such registrations vary widely in whether they supply those particulars.{{r|reports}} | |
| + | 21 | ||
| 20 | == References == | 22 | == References == |
| 21 | {{reflist}} | 23 | {{reflist}} |
| 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="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 25 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 26 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | |
| + | 27 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 24 | 28 | ||
| 25 | {{DEFAULTSORT:Active pharmaceutical ingredient}} | 29 | {{DEFAULTSORT:Active pharmaceutical ingredient}} |
| 26 | [[Category:Drug regulation]] | 30 | [[Category:Drug regulation]] |
| 27 | [[Category:Good manufacturing practice]] | 31 | [[Category:Good manufacturing practice]] |
| + | 32 | [[Category:Manufacturing and supply]] | |
| 28 | 33 |