Contract development and manufacturing organisation: difference between revisions
Diff·revision 10 → 11·02:38, 25 Feb 2025
Difference between revision 10 and revision 11 of Contract development and manufacturing organisation. 10 lines changed; the page grew by 587 bytes.
| Revision 10 — 05:52, 12 Feb 2025 CDMO_Caradoc (talk) add the collapse-temperature point, sourced 2,875 bytes ±0 | Revision 11 — 02:38, 25 Feb 2025 AnalyticalAnnie (talk) clarify that the cake appearance is an indicator, not a specification 3,462 bytes +587 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = Contract development and manufacturing organisation | 2 | | name = Contract development and manufacturing organisation |
| + | 3 | | subtitle = Supply chain role | |
| 3 | | image = facility.svg | 4 | | image = facility.svg |
| 4 | | Abbreviation = CDMO | 5 | | Abbreviation = CDMO |
| ⋮ | ⋮ | ||
| 19 | 20 | ||
| 20 | Quality responsibility is defined by a quality agreement between the parties. In regulated manufacture the marketing authorisation holder remains responsible for the product regardless of who made it, and the agreement allocates the practical obligations.{{r|ich_q7}} | 21 | Quality responsibility is defined by a quality agreement between the parties. In regulated manufacture the marketing authorisation holder remains responsible for the product regardless of who made it, and the agreement allocates the practical obligations.{{r|ich_q7}} |
| + | 22 | ||
| + | 23 | == Consequences for reading documentation == | |
| + | 24 | A [[Certificate of analysis|certificate]] identifies the organisation that performed the determinations, which may or may not be the manufacturer and may or may not be the seller. Where the three differ and the document names only one, the others are simply not established by the document.{{r|iso9001}} | |
| + | 25 | ||
| + | 26 | | Named on the document | What it establishes | | |
| + | 27 | |---|---| | |
| + | 28 | | Testing organisation | Who performed the determinations | | |
| + | 29 | | Manufacturing site | Where the material was made | | |
| + | 30 | | Seller | Who is selling it | | |
| 21 | 31 | ||
| 22 | == References == | 32 | == References == |