Draft standard CEI-MS-12: Residual solvent determination by… — 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-RESIDUAL-SOL/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. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-RESIDUAL-SOL/002. 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…
3. Nothing states how long a prepared standard solution remains usable — arising from DRAFT-RESIDUAL-SOL/003. The procedure now requires solution stability to be demonstrated over the period of intended use, and the demonstration to be recorded with the result.
4. A single method cannot support the conclusion the standard permits — arising from DRAFT-RESIDUAL-SOL/004. The standard now distinguishes a determination of the measured quantity, which stands alone, from a conclusion about the material, which requires a named orthogonal determination, and states that the second claim made on the strength of the first alone is not…
5. A determination does not record the version of the standard it was made under — arising from DRAFT-RESIDUAL-SOL/005. 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.
6. The additional determinations required would materially increase release testing cost — arising from DRAFT-RESIDUAL-SOL/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…
7. A conformance claim is not defined and will be made loosely — arising from DRAFT-RESIDUAL-SOL/007. 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…
8. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-RESIDUAL-SOL/008. Every determination made under this standard now carries a sampling statement recording how many units were sampled, from what population and by what plan, and the standard states that a determination on a single unit supports no inference about any other…
9. References should carry a persistent identifier for every cited source — arising from DRAFT-RESIDUAL-SOL/009. 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.
10. The standard assumes a reference standard of known assigned content — arising from DRAFT-RESIDUAL-SOL/010. 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…
11. The search date is not on the face of the document — arising from DRAFT-RESIDUAL-SOL/011. 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.
12. The preparation solvent is not specified and changes what is measured — arising from DRAFT-RESIDUAL-SOL/012. The preparation solvent is now a required reporting field and the procedure names an acceptable range. Specifying one solvent for every material in scope would exclude compounds the standard is intended to cover.
13. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-RESIDUAL-SOL/013. 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.
14. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-RESIDUAL-SOL/014. 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.
15. Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-RESIDUAL-SOL/015. 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.

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.