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. 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.
2. Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-ENDOTOXIN-ST/002. 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.
3. The standard assumes a reference standard of known assigned content — arising from DRAFT-ENDOTOXIN-ST/003. 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…
4. The standard does not say what to do with a result outside the expected range — arising from DRAFT-ENDOTOXIN-ST/005. 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. The additional determinations required would materially increase release testing cost — arising from DRAFT-ENDOTOXIN-ST/006. 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. Point estimates are given without an interval — arising from DRAFT-ENDOTOXIN-ST/007. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
7. Nothing addresses the container the material was held in — arising from DRAFT-ENDOTOXIN-ST/008. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.
8. The standard specifies how to test a unit and not which units to test — arising from DRAFT-ENDOTOXIN-ST/009. The selection method is now a required field on every report made under this standard, and the limitations section states that a determination on a selected unit supports no inference about the batch.
9. Nothing requires the report to state who performed the determination — arising from DRAFT-ENDOTOXIN-ST/010. The report now requires the identity of the laboratory that performed the determination, its accreditation status where claimed, and a statement of whether the releasing party is the performing party, with the fields classified as critical.
10. The reporting threshold is not tied to a demonstrated limit of quantitation — arising from DRAFT-ENDOTOXIN-ST/011. 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.
11. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-ENDOTOXIN-ST/012. 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.

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.