Draft standard CEI-MS-07: Sub-visible particulate matter in… — 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. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-PARTICULATE-/002. 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…
2. A determination does not record the version of the standard it was made under — arising from DRAFT-PARTICULATE-/007. 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.
3. The search date is not on the face of the document — arising from DRAFT-PARTICULATE-/008. 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.
4. The standard does not say what to do with a result outside the expected range — arising from DRAFT-PARTICULATE-/009. 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.
5. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-PARTICULATE-/011. The suitability criterion is now stated at two levels, a general level achievable on instrumentation in common use and a stricter level required only where the standard is applied to the discrimination named in the scope, with the reason for the difference…
6. A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-PARTICULATE-/005. 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.
7. The reporting threshold is not tied to a demonstrated limit of quantitation — arising from DRAFT-PARTICULATE-/004. The reporting threshold is now conditional on demonstrating the required signal-to-noise at that threshold within the run, and a determination that cannot demonstrate it reports the achievable threshold instead of the nominal one.
8. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-PARTICULATE-/006. 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.
9. The standard assumes a reference standard of known assigned content — arising from DRAFT-PARTICULATE-/010. 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…
10. A field classified as critical is not one a reading turns on — arising from DRAFT-PARTICULATE-/012. 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.
11. A conformance claim is not defined and will be made loosely — arising from DRAFT-PARTICULATE-/003. 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…

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.