VendorInvestigate: difference between revisions
Diff·revision 13 → 14·19:12, 13 Feb 2025
Difference between revision 13 and revision 14 of VendorInvestigate. 4 lines changed; the page grew by 603 bytes.
| Revision 13 — 00:36, 25 Jan 2025 MicrodoseMagnus (talk) add category for certificates of analysis 3,585 bytes +102 | Revision 14 — 19:12, 13 Feb 2025 SurrogateSunday (talk) rm the aggregate pass-rate figure; the denominator is not knowable 4,188 bytes +603 | ||
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| 26 | It is also silent on lot-to-lot consistency, which requires repeated analysis over time, and on [[Underfilling|fill mass]], which requires weighing. A review that finds nothing wrong is evidence of nothing wrong in the documents examined. | 26 | It is also silent on lot-to-lot consistency, which requires repeated analysis over time, and on [[Underfilling|fill mass]], which requires weighing. A review that finds nothing wrong is evidence of nothing wrong in the documents examined. |
| 27 | 27 | ||
| + | 28 | The failure mode most relevant here is [[Test report forgery|forgery]]. A document that has been fabricated to be internally consistent will pass consistency checking, and detecting it requires confirmation with the issuing laboratory rather than inspection of the document, and whether that is possible depends on the laboratory's own reporting practice.{{r|iso17025}} Documentary review can raise the cost of forgery; it cannot eliminate it. | |
| + | 29 | ||
| 28 | == References == | 30 | == References == |
| 29 | {{reflist}} | 31 | {{reflist}} |
| ⋮ | ⋮ | ||
| 31 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 33 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| 32 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 34 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 35 | <ref name="iso17025">ISO/IEC 17025:2017, ''General requirements for the competence of testing and calibration laboratories''.</ref> | |
| 33 | 36 | ||
| 34 | == See also == | 37 | == See also == |
| ⋮ | ⋮ | ||
| 37 | * [[Medutest]] | 40 | * [[Medutest]] |
| 38 | * [[PeptideMeter]] | 41 | * [[PeptideMeter]] |
| + | 42 | * [[Test report forgery]] | |
| 39 | 43 | ||
| 40 | {{DEFAULTSORT:VendorInvestigate}} | 44 | {{DEFAULTSORT:VendorInvestigate}} |