Draft standard: freeze–thaw and in-use stability assessment… — 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 requires the report to state who performed the determination — arising from DRAFT-STABILITY-ST/001. 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.
2. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-STABILITY-ST/002. 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.
3. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-STABILITY-ST/003. 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.
4. A conformance claim is not defined and will be made loosely — arising from DRAFT-STABILITY-ST/004. 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…
5. Nothing addresses the container the material was held in — arising from DRAFT-STABILITY-ST/005. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.
6. The document is unreadable without specialist training — arising from DRAFT-STABILITY-ST/006. 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.
7. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-STABILITY-ST/007. 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…
8. The scope does not say which materials the standard excludes — arising from DRAFT-STABILITY-ST/008. 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.
9. Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-STABILITY-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.
10. The reporting threshold is not tied to a demonstrated limit of quantitation — arising from DRAFT-STABILITY-ST/010. 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. The draft prescribes a procedure where it should state performance — arising from DRAFT-STABILITY-ST/012. The prescriptive clauses are converted to performance requirements, the specific conditions are retained as a worked example clearly labelled as one, and a laboratory using a different validated procedure that meets the stated performance reports a conformant…
12. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-STABILITY-ST/013. 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.
13. The light source is not specified and results will not be comparable — arising from DRAFT-STABILITY-ST/015. The source spectrum is now specified and both exposures are required reporting fields.

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.