Draft standard: bacterial endotoxin testing of peptide… — 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. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-ENDOTOXIN-ST/012. 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.
2. A field classified as critical is not one a reading turns on — arising from DRAFT-ENDOTOXIN-ST/011. 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.
3. A determination does not record the version of the standard it was made under — arising from DRAFT-ENDOTOXIN-ST/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.
4. References should carry a persistent identifier for every cited source — arising from DRAFT-ENDOTOXIN-ST/008. 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.
5. Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-ENDOTOXIN-ST/009. 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.
6. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-ENDOTOXIN-ST/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.
7. The scope does not say which materials the standard excludes — arising from DRAFT-ENDOTOXIN-ST/010. 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.
8. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-ENDOTOXIN-ST/002. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
9. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-ENDOTOXIN-ST/003. 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.
10. The standard does not say what to do with a result outside the expected range — arising from DRAFT-ENDOTOXIN-ST/007. 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.

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.