Contract development and manufacturing organisation: difference between revisions
Diff·revision 14 → 15·03:50, 4 May 2025
Difference between revision 14 and revision 15 of Contract development and manufacturing organisation. 3 lines changed; the page grew by 412 bytes.
| Revision 14 — 07:38, 12 Apr 2025 StopperingSteff (talk) rm the vendor-specific packaging detail; not general enough for the article 3,804 bytes ±0 | Revision 15 — 03:50, 4 May 2025 FreightFenna (talk) expand §Consequences for reading documentation 4,216 bytes +412 | ||
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| 32 | Most research-chemical certificates name one of these. That is a limitation of the document rather than evidence about the arrangement behind it, and inferring a specific structure from a document's silence is unsound. | 32 | Most research-chemical certificates name one of these. That is a limitation of the document rather than evidence about the arrangement behind it, and inferring a specific structure from a document's silence is unsound. |
| 33 | 33 | ||
| + | 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 | ||
| 34 | == References == | 36 | == References == |
| 35 | {{reflist}} | 37 | {{reflist}} |
| 36 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 38 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 37 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 39 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| + | 40 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| 38 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 41 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 39 | 42 |