Public comment period · §3
Draft standard CEI-MS-20: Photostability assessment of… — 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-PHOTOSTABILI/002 | Yusuf Whitmarsh-Obi industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-PHOTOSTABILI/001 | Dr Amara Quaresma | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-PHOTOSTABILI/004 | Dr Katarzyna Yorkstone | A determination does not record the version of the standard it was made under | Accepted |
| DRAFT-PHOTOSTABILI/003 | Dr Lorcan Zaleski-Mbeki | The scope does not say which materials the standard excludes | Accepted |
| 4 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 2 | 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 | 1 | 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-PHOTOSTABILI/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.
- A determination does not record the version of the standard it was made under — arising from DRAFT-PHOTOSTABILI/004. 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.
- The scope does not say which materials the standard excludes — arising from DRAFT-PHOTOSTABILI/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.
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-097/3 · https://compoundevidence.com/comment-periods/draft-photostability-standard/disposition/ · retrieved 30 July 2026