Public comment period · §3
Draft standard CEI-MS-09: Assessment of appearance, cake… — 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-APPEARANCE-S/008 | Hortensia Beauchamp-Ekong industry | The additional determinations required would materially increase release testing cost | Accepted in part |
| DRAFT-APPEARANCE-S/007 | Dr Gervase Abergavenny | The document is unreadable without specialist training | Accepted in part |
| DRAFT-APPEARANCE-S/011 | Dr Anselm Ashworth-Danquah | The document should state what a reader ought to do | Not accepted |
| DRAFT-APPEARANCE-S/005 | Dr Beatrijs Hazelrigg | Nothing requires the report to state who performed the determination | Accepted |
| DRAFT-APPEARANCE-S/006 | Dr Georgiana Zimmerthal | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-APPEARANCE-S/010 | Dr Hyacinth Drakeford-Amadi | The limitations section states what the method cannot do but not what a reader will wrongly conclude | Accepted |
| DRAFT-APPEARANCE-S/013 | Dr Vasilisa Immelmann | Terms are used in senses that differ from established pharmacopoeial usage | Accepted |
| DRAFT-APPEARANCE-S/012 | Dr Bertrand Steenkamp-Ferreira | The scope does not say which materials the standard excludes | Accepted |
| DRAFT-APPEARANCE-S/009 | Professor Bartolomeu Nkosi-Lindegaard | The matrix interferes with the determination and no control is required | Accepted |
| DRAFT-APPEARANCE-S/003 | Hortensia Hollingworth | The search date is not on the face of the document | Accepted |
| DRAFT-APPEARANCE-S/002 | Dr Thaddeus Isaksen-Balogun industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-APPEARANCE-S/004 | Dr Frideswide Hazelrigg | Point estimates are given without an interval | Accepted in part |
| DRAFT-APPEARANCE-S/001 | Dr Melisande Kirkpatrick-Ola | Nothing requires a laboratory to demonstrate ongoing performance | 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 | 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-APPEARANCE-S/008. 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 document is unreadable without specialist training — arising from DRAFT-APPEARANCE-S/007. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
- Nothing requires the report to state who performed the determination — arising from DRAFT-APPEARANCE-S/005. The report now requires the identity of the laboratory that performed the determination, its accreditation status where claimed, and a statement of whether the releasing party is the performing party, with the fields classified as critical.
- The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-APPEARANCE-S/010. 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.
- Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-APPEARANCE-S/013. 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 scope does not say which materials the standard excludes — arising from DRAFT-APPEARANCE-S/012. 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.
- The matrix interferes with the determination and no control is required — arising from DRAFT-APPEARANCE-S/009. 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.
- The search date is not on the face of the document — arising from DRAFT-APPEARANCE-S/003. 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.
- Point estimates are given without an interval — arising from DRAFT-APPEARANCE-S/004. 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 requires a laboratory to demonstrate ongoing performance — arising from DRAFT-APPEARANCE-S/001. 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-095/3 · https://compoundevidence.com/comment-periods/draft-appearance-solubility-standard/disposition/ · retrieved 30 July 2026