Draft certificate-of-analysis minimum data standard
Consultation on the draft standard specifying the minimum data a certificate of analysis must carry before the Institute will treat it as interpretable. The draft classifies each field as critical or recommended and records that a certificate missing a…
§1Consultation and window
§1.1Window
- Opened
- 11 October 2023
- Closed
- 8 November 2023
- Duration
- 28 days
- Status
- Closed — the disposition is published
- Document under consultation
- Standard CEI-MS-14
- Submissions received
- 13
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is the classification of any field as critical rather than recommended disproportionate to what a reader needs in order to interpret the figure?
- Should the standard require the integration start time for a chromatographic purity figure, given that the same chromatogram can yield materially different purities depending on where integration begins?
- Does the standard state clearly enough that a conformant certificate establishes nothing about any batch other than the one tested?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The standard was amended before ratification. Two fields were moved from critical to recommended because no respondent could describe a reading that turned on them, and one field, the integration window, was moved in the opposite direction.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.