Drug master file: difference between revisions
Diff·revision 10 → 11·11:23, 23 Feb 2025
Difference between revision 10 and revision 11 of Drug master file. 11 lines changed; the page grew by 811 bytes.
| Revision 10 — 04:31, 5 Feb 2025 Chromatokid (talk) add the effective date to the regulatory table 2,265 bytes +37 | Revision 11 — 11:23, 23 Feb 2025 FiveOhThreeB (talk) serial comma per PP:MOS 3,076 bytes +811 | ||
|---|---|---|---|
| 21 | Because review occurs only in the context of an application, an unreferenced file has never been assessed. A statement that a substance "has a DMF" therefore says that a document exists, not that it has been found adequate.{{r|fda_dmf}} | 21 | Because review occurs only in the context of an application, an unreferenced file has never been assessed. A statement that a substance "has a DMF" therefore says that a document exists, not that it has been found adequate.{{r|fda_dmf}} |
| 22 | 22 | ||
| + | 23 | == What a DMF claim establishes == | |
| + | 24 | | Claim | What it establishes | | |
| + | 25 | |---|---| | |
| + | 26 | | A DMF has been filed | A document exists with a number | | |
| + | 27 | | A DMF has been referenced | A regulator has reviewed it for one application | | |
| + | 28 | | A DMF has no outstanding deficiencies | Review occurred and was satisfactory | | |
| + | 29 | | Nothing further | The material in a given vial | | |
| + | 30 | ||
| + | 31 | The last row matters here. A DMF describes a process and its controls for a substance intended as an [[Active pharmaceutical ingredient|active pharmaceutical ingredient]]. Material sold as a research chemical is not that substance in the regulatory sense, even where the chemistry is identical.{{r|ich_q7}} | |
| + | 32 | ||
| 23 | == References == | 33 | == References == |
| 24 | {{reflist}} | 34 | {{reflist}} |
| 25 | <ref name="fda_dmf">United States Food and Drug Administration, ''Drug Master Files: Guidelines'' and the published DMF list.</ref> | 35 | <ref name="fda_dmf">United States Food and Drug Administration, ''Drug Master Files: Guidelines'' and the published DMF list.</ref> |
| 26 | <ref name="edqm_cep">European Directorate for the Quality of Medicines, ''Certification of Suitability to the Monographs of the European Pharmacopoeia'' procedure.</ref> | 36 | <ref name="edqm_cep">European Directorate for the Quality of Medicines, ''Certification of Suitability to the Monographs of the European Pharmacopoeia'' procedure.</ref> |
| + | 37 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 27 | 38 | ||
| 28 | {{DEFAULTSORT:Drug master file}} | 39 | {{DEFAULTSORT:Drug master file}} |