7.6 Standardized Versus Laboratory-Developed Procedures
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conducting the assay. Although in this case there is no formal requirement to perform
validation, in practice, selected parameters are used for confirmation of validation.
The choice of these parameters depends on the purpose of the testing.
In the case of environmental studies, one can expect high variability of the
composition of soil (e.g., natural sample versus samples from contaminated
sites), which means that the critical parameter will be the calibration range.
In the case of doping control, it is important to detect whether the prohibited substances are present—hence the critical parameter of evaluation of the
measurement procedure will be the limit of detection and uncertainty.
The use of standard methods has many advantages, unless the analytical parameters of the method and its application area comply with the requirements for the
intended use. However, there are some situations where the standard method is to be
used outside of the validated range, or the laboratory deems it appropriate to modify
the standard analytical procedure. In such cases, it is necessary, according to the
formal requirements, to conduct validation. The scope of the validation should be
appropriate to the specific requirements in relation to the analytical parameters.
Typically, the process of establishing standards is laborious, while in turn the
development of measurement techniques is nowadays extremely fast. Thus, it may
be the case that the given standard is outdated. In such cases, the laboratory may
have its own analytical procedure responding to the demand. This is also valid when
there is no specific standard describing the particular kind of testing. In both cases,
it is necessary to conduct validation.
Measurement procedures requiring validation
– Non-standardized methods developed in laboratory;
– Non-standardized methods described in the scientific literature;
– Standardized methods used outside their scope;
– Standardized methods modified in order to be fit for a purpose.
Measurement procedures requiring confirmation
– Standardized methods.
It should be noted that the purpose of validation is not, in any case, assessment of
the analyst performing the determination, or evaluation of the laboratory. Validation
is primarily aimed at determining the analytical performance of the measurement
procedure in order to decide on its suitability for the intended use. Thus, validation is
a useful tool for evaluating the quality of the results, especially with regard to trade,
and the legal context, as well as in scientific research.
93
conducting the assay. Although in this case there is no formal requirement to perform
validation, in practice, selected parameters are used for confirmation of validation.
The choice of these parameters depends on the purpose of the testing.
In the case of environmental studies, one can expect high variability of the
composition of soil (e.g., natural sample versus samples from contaminated
sites), which means that the critical parameter will be the calibration range.
In the case of doping control, it is important to detect whether the prohibited substances are present—hence the critical parameter of evaluation of the
measurement procedure will be the limit of detection and uncertainty.
The use of standard methods has many advantages, unless the analytical parameters of the method and its application area comply with the requirements for the
intended use. However, there are some situations where the standard method is to be
used outside of the validated range, or the laboratory deems it appropriate to modify
the standard analytical procedure. In such cases, it is necessary, according to the
formal requirements, to conduct validation. The scope of the validation should be
appropriate to the specific requirements in relation to the analytical parameters.
Typically, the process of establishing standards is laborious, while in turn the
development of measurement techniques is nowadays extremely fast. Thus, it may
be the case that the given standard is outdated. In such cases, the laboratory may
have its own analytical procedure responding to the demand. This is also valid when
there is no specific standard describing the particular kind of testing. In both cases,
it is necessary to conduct validation.
Measurement procedures requiring validation
– Non-standardized methods developed in laboratory;
– Non-standardized methods described in the scientific literature;
– Standardized methods used outside their scope;
– Standardized methods modified in order to be fit for a purpose.
Measurement procedures requiring confirmation
– Standardized methods.
It should be noted that the purpose of validation is not, in any case, assessment of
the analyst performing the determination, or evaluation of the laboratory. Validation
is primarily aimed at determining the analytical performance of the measurement
procedure in order to decide on its suitability for the intended use. Thus, validation is
a useful tool for evaluating the quality of the results, especially with regard to trade,
and the legal context, as well as in scientific research.