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ANALYTICAL INSTRUMENT QUALIFICATION
INTRODUCTION
A
large variety of laboratory equipment, instruments, and computerized
analytical systems, ranging from simple nitrogen evaporators to complex
multiple-function technologies (see Instrument Categories),
are used in the pharmaceutical industry to acquire data to help ensure
that products are suitable for their intended use. An analyst's
objective is to consistently obtain reliable and valid data suitable for
the intended purpose. Depending on the applications, users validate
their procedures, calibrate their instruments, and perform additional
instrument checks, such as system suitability tests and analysis of
in-process quality control check samples to help ensure that the
acquired data are reliable. With the increasing sophistication and
automation of analytical instruments, an increasing demand has been
placed on users to qualify their instruments.
Unlike
method validation and system suitability activities, analytical
instrument qualification (AIQ) currently has no specific guidance or
procedures. Competing opinions exist regarding instrument qualification
and validation procedures and the roles and responsibilities of those
who perform them. Consequently, various approaches have been used for
instrument qualification, approaches that require varying amounts of
resources and generate widely differing amounts of documentation. This
chapter provides a scientific approach to AIQ and considers AIQ as one
of the major components required for generating reliable and consistent
data. Note that the amount of rigor applied to the qualification process
will depend on the complexity and intended use of the instrumentation.
This approach emphasizes AIQ's place in the overall process of obtaining
reliable data from analytical instruments.
It is always better to get hold of analytical instrument in your laboratory because of the fact that the impure material can cause problems to you and other people working in that lab.
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