Draft standard CEI-MS-15: Protocol for independent… — 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-THIRD-PARTY-/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. The additional determinations required would materially increase release testing cost — arising from DRAFT-THIRD-PARTY-/011. 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…
3. A determination does not record the version of the standard it was made under — arising from DRAFT-THIRD-PARTY-/008. 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. The search date is not on the face of the document — arising from DRAFT-THIRD-PARTY-/007. 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.
5. A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-THIRD-PARTY-/006. The standard now requires duplicate preparation and injection with a stated maximum difference between the two, and requires that a difference exceeding it be investigated before any figure is reported.
6. The standard assumes a reference standard of known assigned content — arising from DRAFT-THIRD-PARTY-/009. 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…
7. The same concept is given three different names in one document — arising from DRAFT-THIRD-PARTY-/012. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
8. Terms are used in senses that differ from established pharmacopoeial usage — arising from DRAFT-THIRD-PARTY-/005. 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.
9. A conformance claim is not defined and will be made loosely — arising from DRAFT-THIRD-PARTY-/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…

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.