Public comment period · §3
Draft standard CEI-MS-13: Development and validation of a… — 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-STABILITY-IN/001 | Dr Henrike Jastrzębska | The document should state what a reader ought to do | Not accepted |
| DRAFT-STABILITY-IN/002 | Ivo Mountstephen | A determination does not record the version of the standard it was made under | Accepted |
| DRAFT-STABILITY-IN/003 | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes | Accepted in part |
| DRAFT-STABILITY-IN/004 | Leonhard Achterberg | The matrix interferes with the determination and no control is required | Accepted |
| DRAFT-STABILITY-IN/005 | Dr Jolanta Uttridge | Nothing addresses the container the material was held in | Accepted in part |
| DRAFT-STABILITY-IN/006 | Dr Eamon Immelmann | The draft prescribes a procedure where it should state performance | Accepted |
| DRAFT-STABILITY-IN/007 | Dr Melisande Thorsby-Nakamura | Results are reported without an estimate of measurement uncertainty | Accepted in part |
| DRAFT-STABILITY-IN/008 | Dr Evander Whitmarsh-Obi | Nothing states how long a prepared standard solution remains usable | Accepted |
| DRAFT-STABILITY-IN/009 | Dr Yaa Kettlewell | Point estimates are given without an interval | Accepted in part |
| DRAFT-STABILITY-IN/010 | Dr Abimbola Sotomayor-Ekwueme | The standard should state a pass limit | Not accepted |
| DRAFT-STABILITY-IN/011 | Dr Quentin Zimmerthal | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-STABILITY-IN/012 | Dr Zebedee Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-STABILITY-IN/013 | Dr Quentin Enthoven | The document set should be published in translation | Not accepted |
| 13 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 4 | 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 | 6 | 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 | 0 | 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 | 3 | 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
- A determination does not record the version of the standard it was made under — arising from DRAFT-STABILITY-IN/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.
- Nothing prevents a chromatogram being reprocessed until it passes — arising from DRAFT-STABILITY-IN/003. 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.
- The matrix interferes with the determination and no control is required — arising from DRAFT-STABILITY-IN/004. 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.
- Nothing addresses the container the material was held in — arising from DRAFT-STABILITY-IN/005. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.
- The draft prescribes a procedure where it should state performance — arising from DRAFT-STABILITY-IN/006. 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…
- Results are reported without an estimate of measurement uncertainty — arising from DRAFT-STABILITY-IN/007. Every determination now reports the repeatability observed in the run, the reporting precision, and a statement that two results differing by less than the stated repeatability are not distinguishable by this method.
- Nothing states how long a prepared standard solution remains usable — arising from DRAFT-STABILITY-IN/008. The procedure now requires solution stability to be demonstrated over the period of intended use, and the demonstration to be recorded with the result.
- Point estimates are given without an interval — arising from DRAFT-STABILITY-IN/009. 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.
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-STABILITY-IN/011. The standard now states the maximum difference between laboratories analysing the same sample at which results are treated as agreeing, and requires that a comparison across laboratories state whether that criterion was met.
- Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-STABILITY-IN/012. The standard now requires that system suitability results be trended across runs and that a determination report whether the trend was within the laboratory's stated limits, which places the demonstration inside the document the Institute can read.
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-093/3 · https://compoundevidence.com/comment-periods/draft-stability-indicating-standard/disposition/ · retrieved 30 July 2026