PRECISION

Acceptable Range Of Precision

The minimum requirements for the analytical variability

originate from the acceptance criteria of the
specification
However, at least for drug products, better precisions
can usually be achieved. Of course, due to the
additional variance components, acceptance criteria
should be defined for each level of precision
separately.
For the same level of precision, some conclusions can
be drawn from the distribution of standard deviations
or for repeatability.
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For the same level of precision, some conclusions can be drawn

from the distribution of standard deviations, as shown in the
following, for repeatability. For the purpose of evaluation, it is
important to distinguish between individual repeatabilities and
the overall repeatability.
The former can vary in a certain range around the true standard
deviation (depending on the number of determinations, but for the
question of acceptability, the upper limit of the distribution is
relevant.
The latter is an average (pooled) standard deviation describing
the variability within the series, and therefore, due to the
increased degrees of freedom gives a better estimate of the true
(repeatability) standard deviation.

Definitions ICH Guideline Q2A

Intermediate precision expresses withinlaboratories variations: different days, different

analysts, different equipment, etc.
Reproducibility expresses the precision
between laboratories.

INTERMEDIATE PRECISION
It is determined by comparing the results of a method run within a
single laboratory over a number of weeks. A methods intermediate
precision may reect discrepancies in results obtained
from different operators,
from inconsistent working practice (thoroughness) of the same
operator,
from different instruments,
with standards and reagents from different suppliers,
with columns from different batches, or
a combination of these.
The objective of intermediate precision validation is to verify that in the
same laboratory the method will provide the same results once the
development phase is over.

REPRODUCIBILITY
The objective is to verify that the method will provide
the same results in different laboratories. The
reproducibility of an analytical method is determined
by analyzing aliquots from homogeneous lots in
different laboratories with different analysts, and by
using operational and environmental conditions that
may differ from, but are still within, the specied
parameters of the method (inter laboratory tests).
Validation of reproducibility is important if the method
is to be used in different laboratories.
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Summarizes factors that should be the same, or different, for precision,

intermediate precision, and reproducibility.

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EXAMPLE OF THE JOURNAL

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The several methods of validation that

discussed in the journal
Linearity
Precision
Accuracy
Robustness
Ruggedness
LOD & LOQ
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Precision

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