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17/08/2018 7:13 am
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-02089.
17/08/2018 8:12 am
Separate document provenance, identity, purity and the conditions measured. A percentage without its method and sample linkage cannot establish all of those claims.
17/08/2018 9:18 am
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.
17/08/2018 9:20 am
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.
17/08/2018 10:23 am
The index should list supplied evidence and missing evidence separately. Use method-specific wording rather than a blanket verified or safe label.
17/08/2018 10:26 am
Even an authentic analytical report has scope limits. It is not by itself a demonstration of clinical efficacy, sterility or suitability for human use.
17/08/2018 10:54 am
Proposed correction: documentation supplied; method and sample linkage incomplete. Add a dated update if verifiable primary material later resolves those gaps.
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