Draft standard CEI-MS-03: Determination of peptide content… — disposition

§3Disposition and amendments

§3.1Disposition table

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

§3.2Summary by disposition

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

§3.3Resulting amendments

1. A determination does not record the version of the standard it was made under — arising from DRAFT-PEPTIDE-CONT/002. 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. The standard permits a purity figure to be described as an assay — arising from DRAFT-PEPTIDE-CONT/003. The two quantities are now separately defined and the standard states that a chromatographic purity may not be reported as an assay result.
3. Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-PEPTIDE-CONT/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.
4. The preparation solvent is not specified and changes what is measured — arising from DRAFT-PEPTIDE-CONT/005. The preparation solvent is now a required reporting field and the procedure names an acceptable range. Specifying one solvent for every material in scope would exclude compounds the standard is intended to cover.
5. A single method cannot support the conclusion the standard permits — arising from DRAFT-PEPTIDE-CONT/006. The standard now distinguishes a determination of the measured quantity, which stands alone, from a conclusion about the material, which requires a named orthogonal determination, and states that the second claim made on the strength of the first alone is not…
6. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-PEPTIDE-CONT/007. The limitations section now lists the specific conclusions a conformant determination does not support, each stated as a sentence a reader could otherwise have written, and the list is placed before the references rather than in an annex.
7. A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-PEPTIDE-CONT/009. The standard now requires duplicate preparation and injection with a stated maximum difference between the two, and requires that a difference exceeding it be investigated before any figure is reported.
8. The draft prescribes a procedure where it should state performance — arising from DRAFT-PEPTIDE-CONT/010. The prescriptive clauses are converted to performance requirements, the specific conditions are retained as a worked example clearly labelled as one, and a laboratory using a different validated procedure that meets the stated performance reports a conformant…
9. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-PEPTIDE-CONT/011. 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…

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

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