Public comment period · §3
Draft certificate-of-analysis minimum data standard — 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-COA-MINIMUM-/007 | Dr Fenella Lavrentiev | The document set should be published in translation | Not accepted |
| DRAFT-COA-MINIMUM-/009 | Dr Quintus Rautavaara | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-COA-MINIMUM-/012 | Nkechi Larsson-Ekwueme | The search date is not on the face of the document | Accepted |
| DRAFT-COA-MINIMUM-/008 | Ludmila Brackenridge | The standard would be applied more consistently with a worked example | Accepted |
| DRAFT-COA-MINIMUM-/010 | Dr Gervase Crickhowell | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-COA-MINIMUM-/004 | Zdenka Ximenes | Results are reported without an estimate of measurement uncertainty | Accepted in part |
| DRAFT-COA-MINIMUM-/003 | Dr Kamila Glendinning-Uche | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-COA-MINIMUM-/005 | Dr Hamish Nyquist-Obiora | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-COA-MINIMUM-/006 | Dr Marisol Dunmore-Ekpo | The standard does not say what to do with a result outside the expected range | Accepted |
| DRAFT-COA-MINIMUM-/011 | Vittoria Quintanilha | Acceptance criteria are expressed in terms specific to one instrument family | Accepted in part |
| DRAFT-COA-MINIMUM-/013 | Dr Ndidi Ravensworth-Ilunga | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-COA-MINIMUM-/001 | Dr Matthias Whitmarsh-Obi | Terms are used in senses that differ from established pharmacopoeial usage | Accepted |
| DRAFT-COA-MINIMUM-/002 | Dr Wilhelmina Wintringham | The limitations section states what the method cannot do but not what a reader will wrongly conclude | Accepted |
| 13 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 | 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 | 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 | 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 requires a laboratory to demonstrate ongoing performance — arising from DRAFT-COA-MINIMUM-/009. 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.
- The search date is not on the face of the document — arising from DRAFT-COA-MINIMUM-/012. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
- The standard would be applied more consistently with a worked example — arising from DRAFT-COA-MINIMUM-/008. A worked example is added showing the same primary data treated two ways, with both resulting figures stated and the difference between them quantified, so that the consequence of the misapplication is visible rather than described.
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-COA-MINIMUM-/010. 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.
- Results are reported without an estimate of measurement uncertainty — arising from DRAFT-COA-MINIMUM-/004. 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.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-COA-MINIMUM-/003. 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.
- References should carry a persistent identifier for every cited source — arising from DRAFT-COA-MINIMUM-/005. 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.
- The standard does not say what to do with a result outside the expected range — arising from DRAFT-COA-MINIMUM-/006. 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.
- Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-COA-MINIMUM-/011. 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.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-COA-MINIMUM-/013. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
- Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-COA-MINIMUM-/001. 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.
- The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-COA-MINIMUM-/002. 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.
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-003/3 · https://compoundevidence.com/comment-periods/draft-coa-minimum-data-standard/disposition/ · retrieved 30 July 2026