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OTC medicine evaluation
Analytical validation summary
Analytical method number:
Assay/identification (circle) of:
Method type (eg. HPLC, GC, IR):
Performance
parameter
Results
Accuracy
Concentration
determined at (% of
nominal)
Percentage
recovery
Variable assessed (e.g.
analyst, equipment)
Number of
replicates
Typically
determined at
three
concentrations
over the range.
Precision
Page
no.
RSD
Mean
Intermediate
Repeatability
N/A
N/A
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Reference/Publication #
RSD
Met
acceptance
criteria Y/N
Performance
parameter
Results
Linearity/range
Concentration
determined at
(% of nominal)
Page
no.
%,
%,
%,
%,
%,
Met
acceptance
criteria Y/N
%
Correlation
coefficient r2
y-intercept (%)
Specificity
Chromatograms
to support the
specificity of the
method must be
provided.
Include the page
numbers of the
relevant
supporting
chromatograms.
Peaks interfering with
the analyte (Y/N)
Placebo/excipients
Other actives (state)
Related substances (state)
Other (state)
Specificity
Forced
degradation
Forced
degradation
studies may not
be necessary for
active assays
where known
degradants have
been used to
establish
specificity.
Include the page
numbers of the
relevant
supporting
chromatograms.
Y/N
If yes, state any relevant details
(e.g. % decrease in recovery,
stressing conditions)
Decreased
recovery of the
analyte after
stressing.
New peaks
formed.
Any interfering
peaks.
Peak purity
acceptable.
Detection limit
(LOD)
OTC medicine evaluation : Analytical validation summary (July 2014)
For official use only
Page 2 of 3
Performance
parameter
Results
Page
no.
Met
acceptance
criteria Y/N
Quantitation
limit (LOQ)
Other (e.g.
robustness,
solution
stability)
Name
Signature
Date
OTC medicine evaluation : Analytical validation summary (July 2014)
For official use only
Page 3 of 3