ASSURING THE QUALITY OF TEST RESULTS

SAMEH SABER SAMY

DECEMBER 2013

ASSURING THE QUALITY OF TEST RESULTS

1- Calibration of Measuring and Test Equipment
Set of operations which establishes, under specified
conditions, the relationship between values
indicated by a measuring instrument and the
corresponding standard or known values derived
from the standard.

ASSURING THE QUALITY OF TEST RESULTS

2- Use in-house working standards
Working Standards are prepared from supplied raw
materials and standardized against authentic
Reference Substances or primary supplier standards
(if it is not a pharmacopoeial product).

ASSURING THE QUALITY OF TEST RESULTS

3- Validate testing methods
a- Accuracy : is the nearness of a result or the mean of
a set of measurements to the true value.
b- Precision : is the agreement between the set of
replicate measurements without assumption of
knowledge of the true value.
c- Specificity : is the ability to assess clearly the
analyte in the presence of components which may be
expected to be present.
d- Detection limit : is the lowest amount of analyte in
a sample which can be detected but not necessarily
quantitated as an exact value .

ASSURING THE QUALITY OF TEST RESULTS

e- Limit of quantitation: is the level above which
quantitative results may be determined with
acceptable accuracy and precision.
f- Linearity : is the ability of the method to extract
results that are directly proportional to analyte
concentration within a given range.
g- Ruggedness and robustness: is a measure of an
analytical method's capacity to remain unaffected by
small, but deliberate variations in method parameters
and provide an indication of it's reliability during
normal usage.

ASSURING THE QUALITY OF TEST RESULTS

4- Standard
Standard solution is prepared in Duplicate, where
standard 1 is injected five times to calculate the
Relative standard deviation of the injections (N.M.T.
2%)
Precision
and then the response factor between the two
standards is calculated (98 % to 102 %)
Accuracy
and standard 1 is injected more than once during
analysis for continual check of performance.

ASSURING THE QUALITY OF TEST RESULTS

5- Duplicate samples
Test samples are prepared twice and each sample is
measured twice.
Duplicate sample results must be within the normal
variation ( 98%--- 102%).
Precision

ASSURING THE QUALITY OF TEST RESULTS

6- Calculations

Thank You