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-/001 | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes | Accepted in part |
| DRAFT-COA-MINIMUM-/002 | Professor Bartolomeu Nkosi-Lindegaard | A conformance claim is not defined and will be made loosely | Accepted |
| DRAFT-COA-MINIMUM-/003 | Dr Wolfram Quintanilha industry | The additional determinations required would materially increase release testing cost | Accepted in part |
| DRAFT-COA-MINIMUM-/004 | Dr Yusuf Whitmarsh-Obi | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-COA-MINIMUM-/005 | Dr Quentin Zimmerthal | The draft prescribes a procedure where it should state performance | Accepted |
| DRAFT-COA-MINIMUM-/006 | Dr Liesbeth Nyquist-Obiora | The standard should state a pass limit | Not accepted |
| DRAFT-COA-MINIMUM-/007 | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-COA-MINIMUM-/008 | Dr Fitzwilliam Danquah-Öberg | The scope does not say which materials the standard excludes | Accepted |
| DRAFT-COA-MINIMUM-/009 | Eamon Sandringham-Adu | A determination does not record the version of the standard it was made under | Accepted |
| DRAFT-COA-MINIMUM-/010 | Rukayat Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-COA-MINIMUM-/011 | Dr Melisande Thorsby-Nakamura | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-COA-MINIMUM-/012 | Dr Theodora Ingelbrecht | The document should state what a reader ought to do | Not accepted |
| DRAFT-COA-MINIMUM-/013 | Dr Fenella Steenkamp-Ferreira | A field classified as critical is not one a reading turns on | Accepted in part |
| 13 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 6 | 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 | 2 | 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 prevents a chromatogram being reprocessed until it passes — arising from DRAFT-COA-MINIMUM-/001. 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.
- A conformance claim is not defined and will be made loosely — arising from DRAFT-COA-MINIMUM-/002. 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…
- The additional determinations required would materially increase release testing cost — arising from DRAFT-COA-MINIMUM-/003. One of the two determinations is now required only where the stated risk factor is present, with the factor defined in the scope, and the other is retained as a universal requirement with the reasoning stated. The submission is identified as an industry…
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-COA-MINIMUM-/004. 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…
- The draft prescribes a procedure where it should state performance — arising from DRAFT-COA-MINIMUM-/005. 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…
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-COA-MINIMUM-/007. 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.
- The scope does not say which materials the standard excludes — arising from DRAFT-COA-MINIMUM-/008. The scope now states both what the standard applies to and what it does not, with the excluded classes named and, where another standard covers them, cross-referenced.
- A determination does not record the version of the standard it was made under — arising from DRAFT-COA-MINIMUM-/009. 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 requires a laboratory to demonstrate ongoing performance — arising from DRAFT-COA-MINIMUM-/010. 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.
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-COA-MINIMUM-/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.
- A field classified as critical is not one a reading turns on — arising from DRAFT-COA-MINIMUM-/013. The classification test is now stated in the standard: a field is critical where its absence changes the meaning of a reported figure or prevents attribution to a batch. One field has been reclassified under that test and the reasoning recorded.
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