Counterfeit peptide: difference between revisions
Diff·revision 24 → 25·15:23, 30 Oct 2025
Difference between revision 24 and revision 25 of Counterfeit peptide. 3 lines changed; the page grew by 259 bytes.
| Revision 24 — 13:32, 10 Oct 2025 LedgerLysander (talk) rm the inference from one report to a supplier 5,229 bytes ±0 | Revision 25 — 15:23, 30 Oct 2025 EndotoxinEd (talk) expand §Substitution 5,488 bytes +259 | ||
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| 37 | This form is the reason the wiki's supplier articles describe documentary practice rather than only test results. A supplier that consistently issues lot-specific certificates naming its own methods, retrievable years later, is demonstrating something that repackaging cannot easily imitate over time. | 37 | This form is the reason the wiki's supplier articles describe documentary practice rather than only test results. A supplier that consistently issues lot-specific certificates naming its own methods, retrievable years later, is demonstrating something that repackaging cannot easily imitate over time. |
| 38 | 38 | ||
| + | 39 | None of this section should be read as an allegation about any organisation. It describes a category of failure and the kind of evidence that bears on it.{{r|iso9001}} | |
| + | 40 | ||
| 39 | == References == | 41 | == References == |
| 40 | {{reflist}} | 42 | {{reflist}} |
| 41 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 43 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| 42 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 44 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 45 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | |
| 43 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 46 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 44 | 47 |