Public comment period · §3
Draft standard CEI-MS-15: Protocol for independent… — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-THIRD-PARTY-/001 | Dr Lorcan Uttridge | The limitations section states what the method cannot do but not what a reader will wrongly conclude | Accepted |
| DRAFT-THIRD-PARTY-/002 | Quentin Whitmarsh-Obi | A determination does not record the version of the standard it was made under | Accepted |
| DRAFT-THIRD-PARTY-/003 | Rukayat Zaleski-Mbeki | The matrix interferes with the determination and no control is required | Accepted |
| DRAFT-THIRD-PARTY-/004 | Dr Vasilisa Immelmann | A report may be issued without naming who performed the determination | Accepted |
| DRAFT-THIRD-PARTY-/005 | Dr Evander Ashworth-Danquah | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-THIRD-PARTY-/006 | Professor Bartolomeu Nkosi-Lindegaard | Nothing prevents a chromatogram being reprocessed until it passes | Accepted in part |
| DRAFT-THIRD-PARTY-/007 | Dr Jolanta Uttridge | The standard should state a pass limit | Not accepted |
| DRAFT-THIRD-PARTY-/008 | Dr Brigitta Grünbaum-Sowande | Acceptance criteria are expressed in terms specific to one instrument family | Accepted in part |
| DRAFT-THIRD-PARTY-/009 | Dr Evander Whitmarsh-Obi | The draft prescribes a procedure where it should state performance | Accepted |
| DRAFT-THIRD-PARTY-/010 | Dr Hortensia Hollingworth | The standard permits a purity figure to be described as an assay | Accepted |
| DRAFT-THIRD-PARTY-/011 | Dr Fitzwilliam Danquah-Öberg | The reporting threshold is not tied to a demonstrated limit of quantitation | Accepted |
| DRAFT-THIRD-PARTY-/012 | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval | Accepted in part |
| 12 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 7 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 3 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 1 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-THIRD-PARTY-/001. The limitations section now lists the specific conclusions a conformant determination does not support, each stated as a sentence a reader could otherwise have written, and the list is placed before the references rather than in an annex.
- A determination does not record the version of the standard it was made under — arising from DRAFT-THIRD-PARTY-/002. Every determination reported under this standard now carries the standard identifier and version on its face, and a claim of conformance that does not identify the version is recorded by the Institute as not conformant.
- The matrix interferes with the determination and no control is required — arising from DRAFT-THIRD-PARTY-/003. An inhibition and enhancement control is now required for every determination under this standard, with stated recovery limits, and a determination reported without it is recorded as not conformant rather than as a low result.
- A report may be issued without naming who performed the determination — arising from DRAFT-THIRD-PARTY-/004. The performing laboratory is now a required field, and a report without one is recorded as non-conforming with the standard rather than as a report of unknown provenance.
- Nothing prevents a chromatogram being reprocessed until it passes — arising from DRAFT-THIRD-PARTY-/006. The standard now requires the processing method and its version to be recorded with every result and the primary data to be retained. A full audit trail is recommended and not required, since it depends on software many laboratories in scope do not run.
- Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-THIRD-PARTY-/008. The acceptance criteria are now expressed in instrument-independent quantities, with the conversion from the common manufacturer-specific reporting units given in a note so that a laboratory can check conformance without recalculating by hand.
- The draft prescribes a procedure where it should state performance — arising from DRAFT-THIRD-PARTY-/009. The prescriptive clauses are converted to performance requirements, the specific conditions are retained as a worked example clearly labelled as one, and a laboratory using a different validated procedure that meets the stated performance reports a conformant…
- The standard permits a purity figure to be described as an assay — arising from DRAFT-THIRD-PARTY-/010. The two quantities are now separately defined and the standard states that a chromatographic purity may not be reported as an assay result.
- The reporting threshold is not tied to a demonstrated limit of quantitation — arising from DRAFT-THIRD-PARTY-/011. The reporting threshold is now conditional on demonstrating the required signal-to-noise at that threshold within the run, and a determination that cannot demonstrate it reports the achievable threshold instead of the nominal one.
- Point estimates are given without an interval — arising from DRAFT-THIRD-PARTY-/012. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-094/3 · https://compoundevidence.com/comment-periods/draft-third-party-protocol-standard/disposition/ · retrieved 30 July 2026