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4. Does the method, as
written, contain all
appropriate precautions and
warnings related to the
method's reagents,
components, instrumentation,
or method steps that may be
hazardous? If no, please
suggest wording or option(s).
1.
Are the definitions
specified in the SMPR used and
applied appropriately in
the
supporting documentation
(manuscripts, method studies,
etc...)? If not, please explain the
differences and if the method is
impacted by the difference.
2. Is there information
demonstrating that the
method meets the SMPR
Method Performance
Requirements using the
Reference Materials stated in
the SMPR? If not, then
specify what is missing and
how this impacts
demonstration of
performance of the method.
3. Is there information
demonstrating that the
method performs within the
SMPR Method Performance
REquirements table
specifications for all analytes
in the SMPR applicability
statement? If not, please
specify what is missing and
whether or not the method's
applicability should be
modified.
1.
Based on the supporting
information, were there any
additional steps in the
evaluation of the method that
indicated the need for any
additional precautionary
statements in the method?
Yes: The method contains all appropriate precautions and warnings related to the
method’s reagents, components, instrumentation, or method steps that may be
hazardous.
YES: The definitions specified in the SMPR were used and applied appropriately in the
supporting documentation (manuscripts, method studies, etc.).
YES: There are information demonstrating that the method meets the SMPR Method
Performance Requirements using the Reference Material stated in the SMPR.
YES: There are information demonstrating that the method performs within the SMPR
Method Performance Requirements table specifications for all analytes in the SPMR
applicability statement.
In my opinion, there is no need to implement any additional steps in the method
evaluated.
III. Review of Info in
Support of Method:
IV. General
Submission Package: