Consultation record

Submissions accepted — page 19

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

681 documents · page 19 of 23

Table 1. Submissions with this disposition, on this page.

Reference	Consultation	Respondent	Point raised
DRAFT-AGGREGATES-S/005	Draft standard CEI-MS-11: Determination of aggregate content by…	Dr Gervase Crickhowell	A conformance claim is not defined and will be made loosely
DRAFT-AGGREGATES-S/004	Draft standard CEI-MS-11: Determination of aggregate content by…	Dr Rurik Haverkamp-Diallo	Terms are used in senses that differ from established pharmacopoeial usage
DRAFT-AGGREGATES-S/002	Draft standard CEI-MS-11: Determination of aggregate content by…	Ignatius Erlingsson	Quantitative claims are reproduced without the method that produced them
DRAFT-AGGREGATES-S/001	Draft standard CEI-MS-11: Determination of aggregate content by…	Dr Rosalind Grünbaum-Sowande	A determination does not record the version of the standard it was made under
DRAFT-AGGREGATES-S/007	Draft standard CEI-MS-11: Determination of aggregate content by…	Dr Adaeze Dunmore-Ekpo	The standard does not say what to do with a result outside the expected range
DRAFT-RESIDUAL-SOL/008	Draft standard CEI-MS-12: Residual solvent determination by static…	Dr Wilhelmina Erlingsson	Quantitative claims are reproduced without the method that produced them
DRAFT-RESIDUAL-SOL/005	Draft standard CEI-MS-12: Residual solvent determination by static…	Dr Rosalind Grünbaum-Sowande	The limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-RESIDUAL-SOL/011	Draft standard CEI-MS-12: Residual solvent determination by static…	Brigitta Grünbaum-Sowande	Terms are used in senses that differ from established pharmacopoeial usage
DRAFT-RESIDUAL-SOL/010	Draft standard CEI-MS-12: Residual solvent determination by static…	Rosalind Petrossian	Nothing requires the report to state who performed the determination
DRAFT-RESIDUAL-SOL/015	Draft standard CEI-MS-12: Residual solvent determination by static…	Ivo Mountstephen	The standard does not state that a determination on one unit says nothing about the batch
DRAFT-RESIDUAL-SOL/007	Draft standard CEI-MS-12: Residual solvent determination by static…	Dr Adaeze Dunmore-Ekpo	A determination does not record the version of the standard it was made under
DRAFT-RESIDUAL-SOL/013	Draft standard CEI-MS-12: Residual solvent determination by static…	Vasilisa Sandringham-Adu	Rounding conventions are not stated and change the reported result
DRAFT-RESIDUAL-SOL/003	Draft standard CEI-MS-12: Residual solvent determination by static…	Dr Oisín Marchetti-Bassey	The standard would be applied more consistently with a worked example
DRAFT-STABILITY-IN/006	Draft standard CEI-MS-13: Development and validation of a…	Xiomara Fairweather-Duru	The same concept is given three different names in one document
DRAFT-STABILITY-IN/009	Draft standard CEI-MS-13: Development and validation of a…	Dr Adaeze Dunmore-Ekpo	The limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-STABILITY-IN/007	Draft standard CEI-MS-13: Development and validation of a…	Dr Ndidi Ravensworth-Ilunga	The draft prescribes a procedure where it should state performance
DRAFT-STABILITY-IN/004	Draft standard CEI-MS-13: Development and validation of a…	Dr Rurik Underhill-Okafor	Rounding conventions are not stated and change the reported result
DRAFT-THIRD-PARTY-/001	Draft standard CEI-MS-15: Protocol for independent third-party…	Dr Yolanda Norrington-Bhatt	Nothing requires the report to state who performed the determination
DRAFT-THIRD-PARTY-/008	Draft standard CEI-MS-15: Protocol for independent third-party…	Dr Thaddeus Isaksen-Balogun	A determination does not record the version of the standard it was made under
DRAFT-THIRD-PARTY-/007	Draft standard CEI-MS-15: Protocol for independent third-party…	Dr Melisande Kirkpatrick-Ola	The search date is not on the face of the document
DRAFT-THIRD-PARTY-/009	Draft standard CEI-MS-15: Protocol for independent third-party…	Dr Gaspard Wintringham	The standard assumes a reference standard of known assigned content
DRAFT-THIRD-PARTY-/012	Draft standard CEI-MS-15: Protocol for independent third-party…	Professor Chukwuemeka Rasmussen-Adeyemi	The same concept is given three different names in one document
DRAFT-THIRD-PARTY-/005	Draft standard CEI-MS-15: Protocol for independent third-party…	Dr Gervase Abergavenny	Terms are used in senses that differ from established pharmacopoeial usage
DRAFT-THIRD-PARTY-/004	Draft standard CEI-MS-15: Protocol for independent third-party…	Dr Georgiana Zimmerthal	A conformance claim is not defined and will be made loosely
DRAFT-APPEARANCE-S/005	Draft standard CEI-MS-09: Assessment of appearance, cake integrity…	Dr Beatrijs Hazelrigg	Nothing requires the report to state who performed the determination
DRAFT-APPEARANCE-S/010	Draft standard CEI-MS-09: Assessment of appearance, cake integrity…	Dr Hyacinth Drakeford-Amadi	The limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-APPEARANCE-S/013	Draft standard CEI-MS-09: Assessment of appearance, cake integrity…	Dr Vasilisa Immelmann	Terms are used in senses that differ from established pharmacopoeial usage
DRAFT-APPEARANCE-S/012	Draft standard CEI-MS-09: Assessment of appearance, cake integrity…	Dr Bertrand Steenkamp-Ferreira	The scope does not say which materials the standard excludes
DRAFT-APPEARANCE-S/009	Draft standard CEI-MS-09: Assessment of appearance, cake integrity…	Professor Bartolomeu Nkosi-Lindegaard	The matrix interferes with the determination and no control is required
DRAFT-APPEARANCE-S/003	Draft standard CEI-MS-09: Assessment of appearance, cake integrity…	Hortensia Hollingworth	The search date is not on the face of the document

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