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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.
Yes
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.
Yes
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.
No
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?
Method need to be reviewed and re-validated
2. Does the method contain
system suitability tests or
controls as specified by the
SMPR? If not, please indicate
if there is a need for such
tests or controls and which
ones.
Yes, system suitability was carried out as per SMPR
3. Is there information
demonstrating that the
method system suitability
tests and controls as
specified in the SMPR worked
appropriately and as
expected? If no, please
specify.
No, the acceptance criteria set in the method is outside the SMPR