Draft standard CEI-MS-10: Identification and quantification… — 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. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-COUNTER-ION-/004. 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…
2. The same concept is given three different names in one document — arising from DRAFT-COUNTER-ION-/014. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
3. A conformance claim is not defined and will be made loosely — arising from DRAFT-COUNTER-ION-/002. Conformance is now defined as meeting every requirement classified as critical together with the stated system suitability criteria, partial conformance must be described by naming the requirements not met, and a claim of conformance made without the sampling…
4. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-COUNTER-ION-/007. 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.
5. The additional determinations required would materially increase release testing cost — arising from DRAFT-COUNTER-ION-/010. 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…
6. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-COUNTER-ION-/015. 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. The search date is not on the face of the document — arising from DRAFT-COUNTER-ION-/016. 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.
8. A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-COUNTER-ION-/008. 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.
9. The scope does not say which materials the standard excludes — arising from DRAFT-COUNTER-ION-/005. 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.
10. The standard does not say what to do with a result outside the expected range — arising from DRAFT-COUNTER-ION-/011. The standard now requires that every determination performed on a sample be reported, that a repeat be permitted only where an assignable cause is documented, and that the assignable cause be stated on the face of the report.
11. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-COUNTER-ION-/006. 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.
12. References should carry a persistent identifier for every cited source — arising from DRAFT-COUNTER-ION-/003. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
13. A single method cannot support the conclusion the standard permits — arising from DRAFT-COUNTER-ION-/009. 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…
14. The document is unreadable without specialist training — arising from DRAFT-COUNTER-ION-/012. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.

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.