VendorInvestigate: difference between revisions
Diff·revision 3 → 4·06:44, 28 Sep 2024
Difference between revision 3 and revision 4 of VendorInvestigate. 3 lines changed; the page grew by 403 bytes.
| Revision 3 — 03:00, 20 Sep 2024 BlankVialBo (talk) state what the certificate actually carries, field by field 2,190 bytes ±0 | Revision 4 — 06:44, 28 Sep 2024 StubSorterBot (talk) bot: normalise citation format 2,593 bytes +403 | ||
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| 15 | Internal consistency is the most productive of these. A [[Certificate of analysis|certificate]] carries several fields that must agree with each other and with the vial: the lot identifier, the manufacture and retest dates, the method conditions, and the reported determinations. A certificate whose stated method could not produce the reported figure, or whose retest date precedes its manufacture date, is defective on its face without any laboratory work at all.{{r|usp1503}} | 15 | Internal consistency is the most productive of these. A [[Certificate of analysis|certificate]] carries several fields that must agree with each other and with the vial: the lot identifier, the manufacture and retest dates, the method conditions, and the reported determinations. A certificate whose stated method could not produce the reported figure, or whose retest date precedes its manufacture date, is defective on its face without any laboratory work at all.{{r|usp1503}} |
| 16 | 16 | ||
| + | 17 | Registration and certification claims are checkable against public registers. A claimed [[Good manufacturing practice|GMP]] certification names an issuing body, a scope and a validity period, and a claim without those particulars is not checkable — which is itself an observation about the claim.{{r|iso9001}} | |
| + | 18 | ||
| 17 | == References == | 19 | == References == |
| 18 | {{reflist}} | 20 | {{reflist}} |
| 19 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 21 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 22 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | |
| 20 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 23 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 21 | 24 |