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Henry Stewart Talks.
The application of the GLP
principles in analytical chemistry.
This presentation deals with
the application of
the principles of
good laboratory
practice, in short GLP,
in analytical chemistry.
My name is Sergio Caroli,
and I have been one of
the research directors of
the Istituto
Superiore di Sanità,
that is to say, The National
Institute of Health,
at which I was 42 years.
In particular, I was
the delegate for Italy
at the OECD working group on GLP
on its very inception in 1988
until I retired in 2010.
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The adoption of fit-for-purpose
quality systems
is nowadays of
vital importance to
attach credibility to
experimental information
generated in the context
of whatever research,
development, production,
and control activities.
The principles of GLP make no
exception to this general rule,
all the more so, when
analytical determinations
are to be carried out
in the context of
a GLP compliance study,
the results of which
play a crucial role in the
decision-making process.
From this standpoint,
it goes without saying that
all steps of the analysis,
from sampling to
method validation
should be carefully
taken into account.
In a GLP environment,
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standard operating
procedures, in short SOPs,
summarize routine activities
common to a number of studies.
In other words, SOPs are
documented procedures
which describe how to perform
assays or activities,
not normally specified in detail
in study plans or
test guidelines.
Thus, avoiding unnecessary
repetitions in the study plans.
In practice, SOPs are the quality
manual of a test facility.
In the case of
analytical measurements,
SOPs should be
available primarily for
the correct management of
instrumentation of any kind,
ancillary apparatus included,
throughout their
entire life cycle.
