Test report forgery (revision 10)
Old revision·20:13, 12 Jan 2025·NAION_Noel
| Test report forgery | |
|---|---|
| Forms | Fabrication, alteration, misattribution, reuse |
| Detected by | Confirmation with the issuing laboratory |
| Not detected by | Inspection of the document alone |
| Topic infobox · conventions | |
Test report forgery is the fabrication of an analytical report, or the alteration, misattribution or reuse of a genuine one. It is the reason a document cannot by itself establish anything about a material: a document is an assertion, and assertions can be manufactured as easily as the things they describe.[1]
Four distinct practices are usually grouped under the term. A wholly fabricated report describes work never done. An altered report changes figures on a genuine document. A misattributed report is a genuine report on other material presented as covering this one. A reused report is a genuine report on an old lot presented as current.[2]
The last two are the most common and the hardest to detect, because the document is genuine and will survive any inspection of the document itself. What distinguishes them is the relationship between the document and the material, which is a question about traceability rather than about the paper.
Forms and their detectability
[edit]| Form | What is false | Detectable by |
|---|---|---|
| Fabrication | The whole report | Confirmation with the named laboratory |
| Alteration | Specific figures | Confirmation; sometimes internal inconsistency |
| Misattribution | The lot it covers | Lot identifier cross-check |
| Reuse | The date and lot | Date and lot cross-check |
Only the last two are detectable from the document plus the vial, and only if the vial carries a batch number to check against. This is why the presence of a lot identifier on both is more informative than any figure on the certificate.[2]
Fabrication and alteration are detectable in principle by asking the named laboratory whether it issued the report. Whether that is possible depends on the laboratory's practice; some issue reports with a verifiable reference and some do not. A report that cannot be checked with its issuer is not thereby forged — most are not — but it is unconfirmable.[3]
Internal signals
[edit]Some fabrications are visibly defective, and the defects are usually arithmetic or procedural rather than typographic.
- Dates out of order: testing before manufacture, release before testing, retest before release.
- A stated method incapable of producing a reported determination — a purity figure attributed to a method that does not separate, or a water figure attributed to a method that does not measure water.
- Determinations reported to more significant figures than the method supports.
- Related-substance figures that do not sum consistently with the reported main-peak area.
- A chromatogram whose visible integration does not correspond to the stated figure.
References
- ^ PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see Project:Sourcing guidelines).
- ^ a b United States Pharmacopeia, General Chapter <1503>, Quality Attributes of Synthetic Peptide Drug Substances.
- ^ ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, clause 7.8 (reporting of results).