Draft standard CEI-MS-20: Photostability assessment of… — submissions
The 4 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
4 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
A field classified as critical is not one a reading turns on
The respondent has read CEI-MS-20, Photostability assessment of light-sensitive peptides in draft and makes one submission.
The respondent examines the fields classified as critical and states that two of them are administrative rather than interpretive, so that a certificate could be rendered uninterpretable by an omission that changes no reading.
The respondent proposes that a field be classified critical only where its absence changes what the figure means.
The secretariat accepts this submission in part. One field is reclassified as recommended on the test the respondent proposes. The second is retained as critical because its absence prevents the determination being attributed to a batch.
The classification test is now stated in the standard: a field is critical where its absence changes the meaning of a reported figure or prevents attribution to a batch. One field has been reclassified under that test and the reasoning recorded.
The document should state what a reader ought to do
Having read the draft of CEI-MS-20, Photostability assessment of light-sensitive peptides, the respondent puts one point to the secretariat.
The draft assesses evidence and stops. The respondent, a practising clinician, states that a reader arriving at the document with a decision to make is left to convert an assessment into an action without help, and proposes that each document close with a recommendation.
The respondent argues that other evidence bodies issue recommendations and that declining to do so transfers the difficult part of the work to the reader.
The secretariat does not accept this submission, and records that the point is a reasonable one rather than a misunderstanding.
The Institute assesses evidence and does not issue recommendations, because a recommendation embeds values and a resource context that the Institute does not hold and cannot state. That constitutional limit is published on the methodology page and is not varied by consultation. The submission remains published in full.
The standard should state a pass limit
The draft of CEI-MS-20, Photostability assessment of light-sensitive peptides was read by a respondent whose concern is the storage conditions a purchaser can actually achieve.
The respondent states that a standard which reports a figure without a limit leaves the reader without a criterion, and that suppliers will set their own.
The respondent proposes a universal acceptance limit for the determination.
The respondent supports submission 001 so far as it goes and adds the matter set out here.
The secretariat does not accept this submission. An appropriate limit depends on the compound, the presentation and the intended route, none of which the standard fixes.
The standard states performance and reports the figure as determined. Setting a universal limit would attach a pass or fail to materials whose acceptable ranges genuinely differ, which would be a stronger claim than the Institute can support. The submission remains published in full and the point is recorded in the limitations.
A cycle is not defined and the rate of thaw is not controlled
This is a submission on the draft of CEI-MS-20, Photostability assessment of light-sensitive peptides, from a laboratory that stores reconstituted material between determinations.
The procedure requires a stated number of cycles without defining what a cycle is. Rate of freezing and rate of thaw both affect aggregation, and a slow thaw at room temperature is a different exposure from a rapid one in a water bath.
The respondent proposes a definition of a cycle specifying both rates and the hold time at each extreme.
The respondent read submission 003 after drafting this one and has not altered it, the two points being distinct.
The secretariat accepts this submission. An undefined cycle is an uncontrolled variable in a study whose purpose is control.
A cycle is now defined by hold temperature, hold time and thaw method, and all three 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.
- 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
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