Drug master file: difference between revisions
Diff·revision 3 → 4·10:50, 12 Nov 2024
Difference between revision 3 and revision 4 of Drug master file. 2 lines changed; the page grew by 238 bytes.
| Revision 3 — 16:50, 6 Nov 2024 MassSpecMarv (talk) add the note that a certificate of analysis has no regulatory standing 1,551 bytes ±0 | Revision 4 — 10:50, 12 Nov 2024 ImportRecordIna (talk) sentence case in headings per PP:MOS 1,789 bytes +238 | ||
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| 16 | The customer never sees the confidential content. This solves a genuine commercial problem: a manufacturer's process is often its principal asset, and disclosure to a customer who may be a competitor's supplier is unattractive. | 16 | The customer never sees the confidential content. This solves a genuine commercial problem: a manufacturer's process is often its principal asset, and disclosure to a customer who may be a competitor's supplier is unattractive. |
| 17 | 17 | ||
| + | 18 | 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}} | |
| + | 19 | ||
| 18 | == References == | 20 | == References == |
| 19 | {{reflist}} | 21 | {{reflist}} |