Draft standard CEI-MS-08: Related-substances profiling and… — 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. Nothing prevents a chromatogram being reprocessed until it passes — arising from DRAFT-RELATED-SUBS/001. 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.
2. The standard assumes a reference standard of known assigned content — arising from DRAFT-RELATED-SUBS/002. 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…
3. Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-RELATED-SUBS/003. The acceptance criteria are now expressed in instrument-independent quantities, with the conversion from the common manufacturer-specific reporting units given in a note so that a laboratory can check conformance without recalculating by hand.
4. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-RELATED-SUBS/004. 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. A field classified as critical is not one a reading turns on — arising from DRAFT-RELATED-SUBS/005. 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.
6. A determination does not record the version of the standard it was made under — arising from DRAFT-RELATED-SUBS/006. 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.
7. The matrix interferes with the determination and no control is required — arising from DRAFT-RELATED-SUBS/007. An inhibition and enhancement control is now required for every determination under this standard, with stated recovery limits, and a determination reported without it is recorded as not conformant rather than as a low result.
8. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-RELATED-SUBS/008. 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.
9. The document is unreadable without specialist training — arising from DRAFT-RELATED-SUBS/009. 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

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