Consultation record
Submissions accepted — page 20
The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission.
Submissions
735 documents · page 20 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-STERILITY-US/008 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Liesbeth Nyquist-Obiora | Terms are used in senses that differ from established pharmacopoeial usage |
| DRAFT-STERILITY-US/009 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Abimbola Sotomayor-Ekwueme | The standard does not state that a determination on one unit says nothing about the batch |
| DRAFT-STERILITY-US/012 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Jolanta Uttridge | The standard specifies how to test a unit and not which units to test |
| DRAFT-PARTICULATE-/003 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Eamon Immelmann | The scope does not say which materials the standard excludes |
| DRAFT-PARTICULATE-/004 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Marisol Dunmore-Ekpo | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-PARTICULATE-/006 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Ottoline Fitzgerald-Nwosu | The standard assumes a reference standard of known assigned content |
| DRAFT-PARTICULATE-/008 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Stellan Cholmondeley-Ade | The search date is not on the face of the document |
| DRAFT-PARTICULATE-/011 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Vasilisa Immelmann | A conformance claim is not defined and will be made loosely |
| DRAFT-PARTICULATE-/013 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Hortensia Hollingworth | The matrix interferes with the determination and no control is required |
| DRAFT-RELATED-SUBS/002 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Kamila Glendinning-Uche | The standard assumes a reference standard of known assigned content |
| DRAFT-RELATED-SUBS/004 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Xenia Nyquist-Obiora | Terms are used in senses that differ from established pharmacopoeial usage |
| DRAFT-RELATED-SUBS/006 | Draft standard CEI-MS-08: Related-substances profiling and the… | Quentin Whitmarsh-Obi | A determination does not record the version of the standard it was made under |
| DRAFT-RELATED-SUBS/007 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Theodora Trelawney | The matrix interferes with the determination and no control is required |
| DRAFT-COUNTER-ION-/001 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Fenella Steenkamp-Ferreira | The standard would be applied more consistently with a worked example |
| DRAFT-COUNTER-ION-/002 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Abimbola Sotomayor-Ekwueme | The standard does not state that a determination on one unit says nothing about the batch |
| DRAFT-COUNTER-ION-/003 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them |
| DRAFT-COUNTER-ION-/004 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Vasilisa Immelmann | A conformance claim is not defined and will be made loosely |
| DRAFT-COUNTER-ION-/006 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Eamon Immelmann | The scope does not say which materials the standard excludes |
| DRAFT-COUNTER-ION-/008 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Yehudit Yorkstone | The standard assumes a reference standard of known assigned content |
| DRAFT-COUNTER-ION-/009 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Melisande Thorsby-Nakamura | Nothing states how long a prepared standard solution remains usable |
| DRAFT-COUNTER-ION-/010 | Draft standard CEI-MS-10: Identification and quantification of… | Professor Bartolomeu Nkosi-Lindegaard | The standard does not say what to do with a result outside the expected range |
| DRAFT-COUNTER-ION-/013 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Vittoria Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-AGGREGATES-S/002 | Draft standard CEI-MS-11: Determination of aggregate content by… | Ivo Mountstephen | A determination does not record the version of the standard it was made under |
| DRAFT-AGGREGATES-S/003 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Lorcan Uttridge | The matrix interferes with the determination and no control is required |
| DRAFT-AGGREGATES-S/004 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Yehudit Yorkstone | The standard assumes a reference standard of known assigned content |
| DRAFT-AGGREGATES-S/007 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Abimbola Sotomayor-Ekwueme | The standard does not state that a determination on one unit says nothing about the batch |
| DRAFT-AGGREGATES-S/009 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Oisín Rautavaara | Rounding conventions are not stated and change the reported result |
| DRAFT-AGGREGATES-S/011 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Ivo Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-RESIDUAL-SOL/001 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Vasilisa Immelmann | Nothing requires the report to state who performed the determination |
| DRAFT-RESIDUAL-SOL/002 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Adaeze Underhill-Okafor | Absence of evidence is presented in a form a reader will take as negative evidence |
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