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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?
2. 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.
3. Based on the supporting
information, is the method
written clearly and concisely?
If no, please specify the
needed revisions.
4. Based on the supporting
information, what are the
pros/strengths of the
method?
YES
YES
YES, Internal standards should be added prior to the extraction to understand the
actual recoveries of analytes in sample matrices.
YES
YES however SRM results must be reported.
1.Most confirmative method as it is MRM method with eight transitions per allergen.
2. Used SRMs and labeled standards
3. Linearity studies conducted as per SMPR.
IV. General Submission Package: