Contract development and manufacturing organisation: difference between revisions
Diff·revision 18 → 19·04:37, 18 Jul 2025
Difference between revision 18 and revision 19 of Contract development and manufacturing organisation. 5 lines changed; the page grew by 554 bytes.
| Revision 18 — 00:16, 30 Jun 2025 RepackRadek (talk) state that a phase-change pack and a gel pack behave differently 4,240 bytes +24 | Revision 19 — 04:37, 18 Jul 2025 Chromatokid (talk) expand §Consequences for reading documentation 4,794 bytes +554 | ||
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| 34 | Where a claim about in-house manufacture is made, it is checkable in principle against corporate registration and facility records — the kind of documentary review described at [[VendorInvestigate]] — and not checkable at all by analysis of the material.{{r|reports}} | 34 | Where a claim about in-house manufacture is made, it is checkable in principle against corporate registration and facility records — the kind of documentary review described at [[VendorInvestigate]] — and not checkable at all by analysis of the material.{{r|reports}} |
| 35 | 35 | ||
| + | 36 | == Why the arrangement is unremarkable == | |
| + | 37 | Contract manufacture is the normal structure of the fine-chemical industry, including for approved medicines. Treating it as inherently suspicious is not supportable, and a supplier that contracts out manufacture is not thereby doing anything irregular.{{r|ich_q7}} | |
| + | 38 | ||
| + | 39 | What is worth attention is consistency between what is claimed and what is documented. A specific claim about a facility, a certification or a capability is a checkable claim; a general impression conveyed by photographs and adjectives is not. | |
| + | 40 | ||
| 36 | == References == | 41 | == References == |
| 37 | {{reflist}} | 42 | {{reflist}} |