USP 1225
USP 1225
Quality levels of pharmaceutical items are set out in
various test procedures and instruments. US pharmacopeia, which deals with
specifications of drugs and other pharmaceutical products, uses the following
criteria to assess the method validation of these products:
o
accuracy
o
precision
o
specificity
o
detection limit
o
quantitation limit
o
linearity
o
range
o
robustness
Types of test methods
USP 1225 establishes the types of test methods. These are:
o
assay
o
identification
o
testing for impurities – quantitative
o
testing for impurities – limit
o
performance
Specificities of USP
1225
Failure to meet regulatory expectationsunder USP 1225
typically invites statements such as “Failure to establish accuracy,
sensitivity, specificity, and reproducibility of test methods employed by your
firm”, which will be the explanation the FDA gives for failure of compliance,
leading to the issuance of a 483. Such an observation reflects the lack of
understanding of the nuances of method validation on the part of the analyst.
The way out
Test methods that meet USP standards are essentially about
common sense. The analyst has to understand and identify the foundational
aspect of test validation –the intended
use of the test method. This is what enables her to categorize the test method
into one of the types prescribed by the USP. This will be
the gateway to a clearer understanding of the guidance set out in USP 1225.
This is because the underlying matter is that the analyst must prove that the
method performs exactly as intended. This is what forms the basis of the above
criteria and test methods.
References:
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posted by Unknown @ 04:26
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