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. References should carry a persistent identifier for every cited source — arising from DRAFT-STABILITY-ST/007. 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.
2. Point estimates are given without an interval — arising from DRAFT-STABILITY-ST/010. 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.
3. The scope does not say which materials the standard excludes — arising from DRAFT-STABILITY-ST/014. 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.
4. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-STABILITY-ST/008. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
5. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-STABILITY-ST/011. 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.
6. The document is unreadable without specialist training — arising from DRAFT-STABILITY-ST/005. 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. The standard assumes a reference standard of known assigned content — arising from DRAFT-STABILITY-ST/015. 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…
8. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-STABILITY-ST/004. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
9. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-STABILITY-ST/012. 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.
10. Rounding conventions are not stated and change the reported result — arising from DRAFT-STABILITY-ST/001. The standard now requires that no rounding be applied before the reporting step, states the reporting precision for each quantity, and states the rounding convention used at that step.
11. The matrix interferes with the determination and no control is required — arising from DRAFT-STABILITY-ST/003. 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.
12. The search date is not on the face of the document — arising from DRAFT-STABILITY-ST/009. 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.
13. Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-STABILITY-ST/002. 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.

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.