Public comment period · §3
Draft standard CEI-MS-11: Determination of aggregate content… — 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-AGGREGATES-S/012 | Dr Rosalind Grünbaum-Sowande | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-AGGREGATES-S/006 | Dr Quintus Rautavaara | The document set should be published in translation | Not accepted |
| DRAFT-AGGREGATES-S/005 | Dr Gervase Crickhowell | A conformance claim is not defined and will be made loosely | Accepted |
| DRAFT-AGGREGATES-S/003 | Dr Oisín Marchetti-Bassey | A single determination is permitted where duplicates would be inexpensive | Accepted in part |
| DRAFT-AGGREGATES-S/004 | Dr Rurik Haverkamp-Diallo | Terms are used in senses that differ from established pharmacopoeial usage | Accepted |
| DRAFT-AGGREGATES-S/002 | Ignatius Erlingsson | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-AGGREGATES-S/001 | Dr Rosalind Grünbaum-Sowande | A determination does not record the version of the standard it was made under | Accepted |
| DRAFT-AGGREGATES-S/008 | Dr Wilhelmina Erlingsson | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-AGGREGATES-S/009 | Dr Ndidi Ravensworth-Ilunga | Point estimates are given without an interval | Accepted in part |
| DRAFT-AGGREGATES-S/010 | Leonhard Achterberg | Acceptance criteria are expressed in terms specific to one instrument family | Accepted in part |
| DRAFT-AGGREGATES-S/007 | Dr Adaeze Dunmore-Ekpo | The standard does not say what to do with a result outside the expected range | Accepted |
| DRAFT-AGGREGATES-S/011 | Ignatius Erlingsson | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| 12 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | 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 | 5 | 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
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-AGGREGATES-S/012. 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.
- A conformance claim is not defined and will be made loosely — arising from DRAFT-AGGREGATES-S/005. Conformance is now defined as meeting every requirement classified as critical together with the stated system suitability criteria, partial conformance must be described by naming the requirements not met, and a claim of conformance made without the sampling…
- A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-AGGREGATES-S/003. The standard now requires duplicate preparation and injection with a stated maximum difference between the two, and requires that a difference exceeding it be investigated before any figure is reported.
- Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-AGGREGATES-S/004. The three terms now follow established pharmacopoeial usage, the glossary records the definition and its source, and where the Institute uses a term in a narrower sense the departure is stated at first use in the standard.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-AGGREGATES-S/002. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
- A determination does not record the version of the standard it was made under — arising from DRAFT-AGGREGATES-S/001. 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.
- References should carry a persistent identifier for every cited source — arising from DRAFT-AGGREGATES-S/008. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- Point estimates are given without an interval — arising from DRAFT-AGGREGATES-S/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.
- Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-AGGREGATES-S/010. 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 standard does not say what to do with a result outside the expected range — arising from DRAFT-AGGREGATES-S/007. The standard now requires that every determination performed on a sample be reported, that a repeat be permitted only where an assignable cause is documented, and that the assignable cause be stated on the face of the report.
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-091/3 · https://compoundevidence.com/comment-periods/draft-aggregates-sec-standard/disposition/ · retrieved 30 July 2026