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/001 | Dr Fenella Steenkamp-Ferreira | A field classified as critical is not one a reading turns on | Accepted in part |
| DRAFT-PHOTOSTABILI/002 | Dr Zdenka Nyquist-Obiora | The document should state what a reader ought to do | Not accepted |
| DRAFT-PHOTOSTABILI/003 | Dr Liesbeth Nyquist-Obiora | The standard should state a pass limit | Not accepted |
| DRAFT-PHOTOSTABILI/004 | Dr Xenia Nyquist-Obiora | A cycle is not defined and the rate of thaw is not controlled | Accepted |
| 4 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 1 | 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 | 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
- A field classified as critical is not one a reading turns on — arising from DRAFT-PHOTOSTABILI/001. 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.
- A cycle is not defined and the rate of thaw is not controlled — arising from DRAFT-PHOTOSTABILI/004. A cycle is now defined by hold temperature, hold time and thaw method, and all three are required reporting fields.
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