Consultation record
Submissions accepted in part — page 10
Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.
Submissions
390 documents · page 10 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-PARTICULATE-/001 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Liesbeth Nordhagen industry | The additional determinations required would materially increase release testing cost |
| DRAFT-PARTICULATE-/007 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Thaddeus Isaksen-Balogun | A single determination is permitted where duplicates would be inexpensive |
| DRAFT-PARTICULATE-/010 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Theodora Trelawney | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-PARTICULATE-/012 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Jolyon Grünbaum-Sowande | A single method cannot support the conclusion the standard permits |
| DRAFT-RELATED-SUBS/001 | Draft standard CEI-MS-08: Related-substances profiling and the… | Professor Bartolomeu Nkosi-Lindegaard | Nothing prevents a chromatogram being reprocessed until it passes |
| DRAFT-RELATED-SUBS/003 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Jolyon Grünbaum-Sowande | Acceptance criteria are expressed in terms specific to one instrument family |
| DRAFT-RELATED-SUBS/005 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Fenella Steenkamp-Ferreira | A field classified as critical is not one a reading turns on |
| DRAFT-RELATED-SUBS/008 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Zebedee Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-RELATED-SUBS/009 | Draft standard CEI-MS-08: Related-substances profiling and the… | Ms Rhiannon Okoye-Vandergraaf | The document is unreadable without specialist training |
| DRAFT-COUNTER-ION-/005 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Fitzwilliam Danquah-Öberg | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-COUNTER-ION-/011 | Draft standard CEI-MS-10: Identification and quantification of… | Rukayat Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-COUNTER-ION-/012 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Eulalia Sonnenberg-Eze | The preparation solvent is not specified and changes what is measured |
| DRAFT-COUNTER-ION-/015 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Séverine Oduya-Kaltenbrunner | A single method cannot support the conclusion the standard permits |
| DRAFT-AGGREGATES-S/005 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-AGGREGATES-S/006 | Draft standard CEI-MS-11: Determination of aggregate content by… | Bertrand Ollerenshaw industry | The additional determinations required would materially increase release testing cost |
| DRAFT-AGGREGATES-S/008 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Quentin Zimmerthal | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-AGGREGATES-S/010 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Liesbeth Achterberg | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-AGGREGATES-S/012 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Xenia Nyquist-Obiora | Nothing addresses the container the material was held in |
| DRAFT-RESIDUAL-SOL/004 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Sigrún Vercingetorix | A single method cannot support the conclusion the standard permits |
| DRAFT-RESIDUAL-SOL/006 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Perpetua Haverkamp-Diallo industry | The additional determinations required would materially increase release testing cost |
| DRAFT-RESIDUAL-SOL/009 | Draft standard CEI-MS-12: Residual solvent determination by static… | Ivo Mountstephen | References should carry a persistent identifier for every cited source |
| DRAFT-RESIDUAL-SOL/012 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Gervase Abergavenny | The preparation solvent is not specified and changes what is measured |
| DRAFT-RESIDUAL-SOL/014 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Evander Whitmarsh-Obi | Results are reported without an estimate of measurement uncertainty |
| DRAFT-RESIDUAL-SOL/015 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Fitzwilliam Danquah-Öberg | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-STABILITY-IN/003 | Draft standard CEI-MS-13: Development and validation of a… | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes |
| DRAFT-STABILITY-IN/005 | Draft standard CEI-MS-13: Development and validation of a… | Dr Jolanta Uttridge | Nothing addresses the container the material was held in |
| DRAFT-STABILITY-IN/007 | Draft standard CEI-MS-13: Development and validation of a… | Dr Melisande Thorsby-Nakamura | Results are reported without an estimate of measurement uncertainty |
| DRAFT-STABILITY-IN/009 | Draft standard CEI-MS-13: Development and validation of a… | Dr Yaa Kettlewell | Point estimates are given without an interval |
| DRAFT-STABILITY-IN/011 | Draft standard CEI-MS-13: Development and validation of a… | Dr Quentin Zimmerthal | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-STABILITY-IN/012 | Draft standard CEI-MS-13: Development and validation of a… | Dr Zebedee Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance |
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