Public comment period · §3
Draft standard CEI-MS-06: Sterility testing of peptide… — 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-STERILITY-US/005 | Dr Lorcan Uttridge industry | The additional determinations required would materially increase release testing cost | Accepted in part |
| DRAFT-STERILITY-US/003 | Sigrún Vercingetorix | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-STERILITY-US/002 | Dr Piotr Hollingworth | The search date is not on the face of the document | Accepted |
| DRAFT-STERILITY-US/004 | Dr Odalys Thorsby-Nakamura | The matrix interferes with the determination and no control is required | Accepted |
| DRAFT-STERILITY-US/013 | Ivo Mountstephen | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-STERILITY-US/010 | Dr Sigrún Lavrentiev | Results are reported without an estimate of measurement uncertainty | Accepted in part |
| DRAFT-STERILITY-US/008 | Dr Gaspard Wintringham | The standard assumes a reference standard of known assigned content | Accepted |
| DRAFT-STERILITY-US/009 | Radoslava Palmgren-Kofi | Point estimates are given without an interval | Accepted in part |
| DRAFT-STERILITY-US/001 | Dr Ursina Ellsworth-Vance | The document should state what a reader ought to do | Not accepted |
| DRAFT-STERILITY-US/011 | Dr Theodora Trelawney | Terms are used in senses that differ from established pharmacopoeial usage | Accepted |
| DRAFT-STERILITY-US/006 | Dr Jacinta Grünbaum-Sowande | The document set should be published in translation | Not accepted |
| DRAFT-STERILITY-US/012 | Dr Eamon Sandringham-Adu | The scope does not say which materials the standard excludes | Accepted |
| DRAFT-STERILITY-US/007 | Dr Oisín Rautavaara industry | Two factual descriptions of the sponsor's programme are inaccurate | 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 | 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
- The additional determinations required would materially increase release testing cost — arising from DRAFT-STERILITY-US/005. 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…
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-STERILITY-US/003. 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.
- The search date is not on the face of the document — arising from DRAFT-STERILITY-US/002. 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.
- The matrix interferes with the determination and no control is required — arising from DRAFT-STERILITY-US/004. 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.
- Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-STERILITY-US/013. 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.
- Results are reported without an estimate of measurement uncertainty — arising from DRAFT-STERILITY-US/010. Every determination now reports the repeatability observed in the run, the reporting precision, and a statement that two results differing by less than the stated repeatability are not distinguishable by this method.
- The standard assumes a reference standard of known assigned content — arising from DRAFT-STERILITY-US/008. 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…
- Point estimates are given without an interval — arising from DRAFT-STERILITY-US/009. 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.
- Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-STERILITY-US/011. 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-STERILITY-US/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.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-STERILITY-US/007. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
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-087/3 · https://compoundevidence.com/comment-periods/draft-sterility-usp71-standard/disposition/ · retrieved 30 July 2026