Drug master file: difference between revisions
Diff·revision 19 → 20·11:03, 21 Aug 2025
Difference between revision 19 and revision 20 of Drug master file. 3 lines changed; the page grew by 233 bytes.
| Revision 19 — 15:21, 26 Jul 2025 ImportRecordIna (talk) add the citation for the regulatory action 4,092 bytes ±0 | Revision 20 — 11:03, 21 Aug 2025 TrialsTabitha (talk) attribute the compounding statement to the pharmacy board that issued it 4,325 bytes +233 | ||
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| 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}} | 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 | 39 | ||
| + | 40 | That is a documentary observation and not an allegation about any organisation.{{r|usp1503}} | |
| + | 41 | ||
| 40 | == References == | 42 | == References == |
| 41 | {{reflist}} | 43 | {{reflist}} |
| ⋮ | ⋮ | ||
| 45 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 47 | <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> | 48 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 49 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 47 | 50 | ||
| 48 | == See also == | 51 | == See also == |