Public comment period · §3
Draft standard CEI-MS-07: Sub-visible particulate matter in… — 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-PARTICULATE-/001 | Dr Liesbeth Nordhagen industry | The additional determinations required would materially increase release testing cost | Accepted in part |
| DRAFT-PARTICULATE-/002 | Professor Bartolomeu Nkosi-Lindegaard | The standard does not require retention of the primary data | Noted, no amendment |
| DRAFT-PARTICULATE-/003 | Dr Eamon Immelmann | The scope does not say which materials the standard excludes | Accepted |
| DRAFT-PARTICULATE-/004 | Dr Marisol Dunmore-Ekpo | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-PARTICULATE-/005 | Dr Jolanta Uttridge | The standard should state a pass limit | Not accepted |
| DRAFT-PARTICULATE-/006 | Dr Ottoline Fitzgerald-Nwosu | The standard assumes a reference standard of known assigned content | Accepted |
| DRAFT-PARTICULATE-/007 | Thaddeus Isaksen-Balogun | A single determination is permitted where duplicates would be inexpensive | Accepted in part |
| DRAFT-PARTICULATE-/008 | Stellan Cholmondeley-Ade | The search date is not on the face of the document | Accepted |
| DRAFT-PARTICULATE-/009 | Dr Liesbeth Achterberg | The standard should require documented operator competence | Not accepted |
| DRAFT-PARTICULATE-/010 | Dr Theodora Trelawney | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-PARTICULATE-/011 | Dr Vasilisa Immelmann | A conformance claim is not defined and will be made loosely | Accepted |
| DRAFT-PARTICULATE-/012 | Dr Jolyon Grünbaum-Sowande | A single method cannot support the conclusion the standard permits | Accepted in part |
| DRAFT-PARTICULATE-/013 | Dr Hortensia Hollingworth | The matrix interferes with the determination and no control is required | Accepted |
| 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 | 4 | 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 | 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
- The additional determinations required would materially increase release testing cost — arising from DRAFT-PARTICULATE-/001. 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…
- The scope does not say which materials the standard excludes — arising from DRAFT-PARTICULATE-/003. 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.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-PARTICULATE-/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 standard assumes a reference standard of known assigned content — arising from DRAFT-PARTICULATE-/006. The standard now states which determinations remain available without a reference standard of assigned content, requires that such determinations be labelled as relative rather than absolute, and requires the assumption used in place of an assigned content to…
- A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-PARTICULATE-/007. 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.
- The search date is not on the face of the document — arising from DRAFT-PARTICULATE-/008. 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.
- Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-PARTICULATE-/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.
- A conformance claim is not defined and will be made loosely — arising from DRAFT-PARTICULATE-/011. 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 method cannot support the conclusion the standard permits — arising from DRAFT-PARTICULATE-/012. The standard now distinguishes a determination of the measured quantity, which stands alone, from a conclusion about the material, which requires a named orthogonal determination, and states that the second claim made on the strength of the first alone is not…
- The matrix interferes with the determination and no control is required — arising from DRAFT-PARTICULATE-/013. 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.
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-088/3 · https://compoundevidence.com/comment-periods/draft-particulate-usp788-standard/disposition/ · retrieved 30 July 2026