Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Public comment period · §3

Draft standard CEI-MS-02: Confirmation of peptide identity by… — disposition

The disposition of every submission and the amendments that resulted.

Document identifier
CEI-CP-084/3
Series
Public comment period
Version
1.0
Published
21 Mar 2024
Last reviewed
21 Mar 2024
Next review
21 Mar 2025
Identifier
10.71829/cei.cp.84
Certainty
Not rated
Cycle
2024 Q1
Window
10 Jan 2024 – 24 Feb 2024
Status
Closed
Submissions
6

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

ReferenceRespondentPoint raisedDisposition
DRAFT-LCMSMS-IDENT/001Anselm MountstephenA determination does not record the version of the standard it was made underAccepted
DRAFT-LCMSMS-IDENT/002Dr Zebedee Zaleski-MbekiNothing requires a laboratory to demonstrate ongoing performanceAccepted in part
DRAFT-LCMSMS-IDENT/003Dr Abimbola Sotomayor-EkwuemeThe standard does not state that a determination on one unit says nothing about the batchAccepted
DRAFT-LCMSMS-IDENT/004Dr Quentin ZimmerthalResults are reported without an estimate of measurement uncertaintyAccepted in part
DRAFT-LCMSMS-IDENT/005Georgiana ZimmerthalThe document set should be published in translationNot accepted
DRAFT-LCMSMS-IDENT/006Dr Liesbeth Nyquist-ObioraNothing addresses the container the material was held inAccepted in part
6 submissions in total.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

DispositionCountMeaning
Accepted2The 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 part3Part 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 amendment0The 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 accepted1The 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

  1. A determination does not record the version of the standard it was made under — arising from DRAFT-LCMSMS-IDENT/001. 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.
  2. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-LCMSMS-IDENT/002. 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.
  3. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-LCMSMS-IDENT/003. 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…
  4. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-LCMSMS-IDENT/004. 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.
  5. Nothing addresses the container the material was held in — arising from DRAFT-LCMSMS-IDENT/006. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.

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.

  1. 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.

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