Blind sampling: difference between revisions
Diff·revision 12 → 13·14:04, 1 Mar 2025
Difference between revision 12 and revision 13 of Blind sampling. 5 lines changed; the page grew by 1,130 bytes.
| Revision 12 — 08:03, 12 Feb 2025 Chromatokid (talk) add the retest interval and what triggers one 5,650 bytes +676 | Revision 13 — 14:04, 1 Mar 2025 SupplyWatchSuri (talk) add the laboratory accreditation status, or say plainly that it is not stated 6,780 bytes +1,130 | ||
|---|---|---|---|
| 34 | In the research-compound sector there is no obligation and no authority. The parties with a reason to test are purchasers, who are testing their own material because they want to know about their own material, and testing services, which test what is sent to them. Neither is positioned to run a sampling plan.{{r|reports}} | 34 | In the research-compound sector there is no obligation and no authority. The parties with a reason to test are purchasers, who are testing their own material because they want to know about their own material, and testing services, which test what is sent to them. Neither is positioned to run a sampling plan.{{r|reports}} |
| 35 | 35 | ||
| + | 36 | A small number of arrangements approximate blinding without achieving it. A purchaser ordering under a name unconnected with any published tally has removed the supplier's ability to identify the order, which addresses failure mode 1 while leaving 2 and 3 untouched. A tally that records every submission received rather than every submission its contributors chose to publicise reduces the third. Neither should be described as blind, and this wiki does not. | |
| + | 37 | ||
| 36 | === What a non-blind result still establishes === | 38 | === What a non-blind result still establishes === |
| 37 | The limitation is not a reason to disregard the reports; it is a reason to state what they support. A non-blind, purchaser-selected result on a single vial establishes, without qualification: | 39 | The limitation is not a reason to disregard the reports; it is a reason to state what they support. A non-blind, purchaser-selected result on a single vial establishes, without qualification: |
| ⋮ | ⋮ | ||
| 41 | * that the vial did or did not carry a lot identifier matching its certificate and invoice. | 43 | * that the vial did or did not carry a lot identifier matching its certificate and invoice. |
| 42 | 44 | ||
| + | 45 | The second and third are checks on documentation rather than on material, and documentation is the thing a purchaser can actually verify. This is why the supplier articles on this wiki describe documentation practice at length and describe quality only in terms of what the reports say about the samples tested.{{r|reports}} It is also why the determinations a purchaser can ask for are enumerated rather than summarised: each is checkable on the document in front of them.{{r|usp1503}} | |
| + | 46 | ||
| 43 | == References == | 47 | == References == |
| 44 | {{reflist}} | 48 | {{reflist}} |
| ⋮ | ⋮ | ||
| 46 | <ref name="reports">Purchaser-submitted test reports held by PeptidePedia, 2024–2026, together with the submission metadata recorded with them. None arose from a documented sampling procedure.</ref> | 50 | <ref name="reports">Purchaser-submitted test reports held by PeptidePedia, 2024–2026, together with the submission metadata recorded with them. None arose from a documented sampling procedure.</ref> |
| 47 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. Treats sampling as a quality-system responsibility distinct from the analysis performed on the sample.</ref> | 51 | <ref name="gmp">World Health Organization, ''Good Manufacturing Practices for Pharmaceutical Products: Main Principles'', WHO Technical Report Series. Treats sampling as a quality-system responsibility distinct from the analysis performed on the sample.</ref> |
| + | 52 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision.</ref> | |
| 48 | 53 | ||
| 49 | == See also == | 54 | == See also == |