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/001 | Dr Xenia Nyquist-Obiora | The standard should state a pass limit | Not accepted |
| DRAFT-STERILITY-US/002 | Dr Yaa Kettlewell | Point estimates are given without an interval | Accepted in part |
| DRAFT-STERILITY-US/003 | Dr Frideswide Nordhagen | The standard would be applied more consistently with a worked example | Accepted |
| DRAFT-STERILITY-US/004 | Dr Anselm Thorsby-Nakamura | Nothing in the standard addresses transfer of the method between laboratories | Accepted in part |
| DRAFT-STERILITY-US/005 | Dr Fitzwilliam Danquah-Öberg | Results are reported without an estimate of measurement uncertainty | Accepted in part |
| DRAFT-STERILITY-US/006 | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes | Accepted in part |
| DRAFT-STERILITY-US/007 | Dr Zdenka Nyquist-Obiora | The document should state what a reader ought to do | Not accepted |
| DRAFT-STERILITY-US/008 | Dr Liesbeth Nyquist-Obiora | Terms are used in senses that differ from established pharmacopoeial usage | Accepted |
| DRAFT-STERILITY-US/009 | Dr Abimbola Sotomayor-Ekwueme | The standard does not state that a determination on one unit says nothing about the batch | Accepted |
| DRAFT-STERILITY-US/010 | Dr Theodora Trelawney | Nothing requires a laboratory to demonstrate ongoing performance | Accepted in part |
| DRAFT-STERILITY-US/011 | Eamon Sandringham-Adu | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-STERILITY-US/012 | Dr Jolanta Uttridge | The standard specifies how to test a unit and not which units to test | Accepted |
| DRAFT-STERILITY-US/013 | Dr Hyacinth Drakeford-Amadi | A field classified as critical is not one a reading turns on | 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 | 4 | 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 | 6 | 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
- Point estimates are given without an interval — arising from DRAFT-STERILITY-US/002. 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.
- The standard would be applied more consistently with a worked example — arising from DRAFT-STERILITY-US/003. A worked example is added showing the same primary data treated two ways, with both resulting figures stated and the difference between them quantified, so that the consequence of the misapplication is visible rather than described.
- Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-STERILITY-US/004. 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.
- Results are reported without an estimate of measurement uncertainty — arising from DRAFT-STERILITY-US/005. 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.
- Nothing prevents a chromatogram being reprocessed until it passes — arising from DRAFT-STERILITY-US/006. The standard now requires the processing method and its version to be recorded with every result and the primary data to be retained. A full audit trail is recommended and not required, since it depends on software many laboratories in scope do not run.
- Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-STERILITY-US/008. 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 standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-STERILITY-US/009. Every determination made under this standard now carries a sampling statement recording how many units were sampled, from what population and by what plan, and the standard states that a determination on a single unit supports no inference about any other…
- Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-STERILITY-US/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.
- The standard specifies how to test a unit and not which units to test — arising from DRAFT-STERILITY-US/012. The selection method is now a required field on every report made under this standard, and the limitations section states that a determination on a selected unit supports no inference about the batch.
- A field classified as critical is not one a reading turns on — arising from DRAFT-STERILITY-US/013. 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.
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