Contract development and manufacturing organisation: difference between revisions
Diff·revision 4 → 5·07:32, 9 Dec 2024
Difference between revision 4 and revision 5 of Contract development and manufacturing organisation. 2 lines changed; the page grew by 269 bytes.
| Revision 4 — 23:39, 28 Nov 2024 CouplingCillian (talk) expand §Consequences for reading documentation 2,252 bytes ±0 | Revision 5 — 07:32, 9 Dec 2024 FmocFrancis (talk) correct the transit-time figure — the source gives a median, not a maximum 2,521 bytes +269 | ||
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| 15 | For peptides the capability that matters is [[Solid-phase peptide synthesis|synthesis]] at scale with the associated [[Preparative HPLC purification|preparative chromatography]], since the purification step is the one that requires the largest capital equipment. A house able to synthesise but not to purify at scale is limited to crude supply, and the distinction shows up in the specification a customer can be offered rather than in any claim about capability.{{r|usp1503}} | 15 | For peptides the capability that matters is [[Solid-phase peptide synthesis|synthesis]] at scale with the associated [[Preparative HPLC purification|preparative chromatography]], since the purification step is the one that requires the largest capital equipment. A house able to synthesise but not to purify at scale is limited to crude supply, and the distinction shows up in the specification a customer can be offered rather than in any claim about capability.{{r|usp1503}} |
| 16 | 16 | ||
| + | 17 | 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}} | |
| + | 18 | ||
| 17 | == References == | 19 | == References == |
| 18 | {{reflist}} | 20 | {{reflist}} |