Chemistry Reference
In-Depth Information
tAble 2.5
sample detector linearity result Form
Detector Serial Number
Test Apparatus
Flow Cell (Initials)
Cuvettes (Initials)
Flow Cell Type and
Path Length
solution Id/lot number
expiration date
solution concentration
(mg/ml from coA)
Absorbance
sensitivity (Absorbance/
concentration)
0
5
10
15
20
25
30
Sensitivity Mean
Sensitivity Standard Deviation
% RSD
Specification
<4.5%
Test Result
Pass (Initials)
Fail (Initials)
Comments
Certification
The Performer as signed below attests that the test was performed according to the
prescribed procedure and that the results above are accurate and complete.
Performer
Signature
Date
The Reviewer as signed below attests that the test was performed according to the
prescribed procedure and that the results above are accurate and complete.
Reviewer
Signature
Date
depends on such things as the ruggedness of the instrument, and the criticality and
frequency of use. PQ testing at periodic intervals can also be used to compile an
instrument performance history.
In practice, a known method, with known predetermined specifications, is used to
verify that all the modules are performing together to achieve their intended purpose.
In practice, OQ and PQ frequently blend together in a holistic approach, particu-
larly for injector linearity and precision (repeatability) tests, which can be conducted
more easily at the system level. For HPLC, the PQ test should use a method with a
well-characterized analyte mixture, column, and mobile phase. Figure 2.3 shows
an example of a “vendor” PQ test method HPLC separation that incorporates the
