Notifications
Clear all
Reading the evidence
7
Posts
7
Users
0
Reactions
1
Views
Topic starter
20/09/2019 5:27 pm
A reagent dossier contains a summary purity percentage but not the method or underlying trace. The draft index calls it fully verified. Which parts of that label can actually be supported?
Discussion record: RESEARCH-05977.
20/09/2019 6:52 pm
Ask whether the sample identifier, issuing laboratory, report date and relevant analytical method can be verified. A copied certificate may be genuine as a document while its relationship to the sample remains unestablished.
20/09/2019 6:53 pm
Separate document provenance, identity, purity and the conditions measured. A percentage without its method and sample linkage cannot establish all of those claims.
20/09/2019 7:18 pm
A chromatographic peak-area figure and net material content answer different questions. Record the report’s own definition and units before comparing it with another percentage.
20/09/2019 8:01 pm
The index should list supplied evidence and missing evidence separately. Use method-specific wording rather than a blanket verified or safe label.
20/09/2019 8:15 pm
Even an authentic analytical report has scope limits. It is not by itself a demonstration of clinical efficacy, sterility or suitability for human use.
20/09/2019 9:20 pm
Proposed correction: documentation supplied; method and sample linkage incomplete. Add a dated update if verifiable primary material later resolves those gaps.
Share: