Drug master file: difference between revisions
Diff·revision 16 → 17·05:42, 14 Jun 2025
Difference between revision 16 and revision 17 of Drug master file. 7 lines changed; the page grew by 750 bytes.
| Revision 16 — 07:11, 27 May 2025 PharmDrafts (talk) rm the speculation about future scheduling 3,342 bytes ±0 | Revision 17 — 05:42, 14 Jun 2025 EndotoxinEd (talk) add the jurisdiction to the legal statement 4,092 bytes +750 | ||
|---|---|---|---|
| 33 | DMF numbers are published in regulator lists, so the existence of a filing is checkable. Its status generally is not.{{r|fda_dmf}} | 33 | DMF numbers are published in regulator lists, so the existence of a filing is checkable. Its status generally is not.{{r|fda_dmf}} |
| 34 | 34 | ||
| + | 35 | == Relevance to this wiki == | |
| + | 36 | Supplier documentation sometimes cites a DMF number as evidence of quality. It is evidence of a filing, which is a real thing and a checkable one, and it is not evidence about a research-chemical lot.{{r|reports}} | |
| + | 37 | ||
| + | 38 | The general shape is the same as for [[ISO 9001]] and [[Good manufacturing practice|GMP]] claims: each is a genuine and verifiable claim about an organisation or a process, each is checkable with particulars, and none is a statement about the material in a vial.{{r|iso9001}} | |
| + | 39 | ||
| 35 | == References == | 40 | == References == |
| 36 | {{reflist}} | 41 | {{reflist}} |
| ⋮ | ⋮ | ||
| 38 | <ref name="edqm_cep">European Directorate for the Quality of Medicines, ''Certification of Suitability to the Monographs of the European Pharmacopoeia'' procedure.</ref> | 43 | <ref name="edqm_cep">European Directorate for the Quality of Medicines, ''Certification of Suitability to the Monographs of the European Pharmacopoeia'' procedure.</ref> |
| 39 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 44 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| + | 45 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | |
| + | 46 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 40 | 47 | ||
| 41 | == See also == | 48 | == See also == |