Chemistry Reference
In-Depth Information
and in-process quality control checks to ensure that the data they acquire is reli-
able, and there are specific guidance and procedures available to ensure compliance
[4-8]. Until recently, however, there was no specific guidance or procedures dictat-
ing what constituted AIQ, the process of ensuring that an
instrument
is suitable for
its intended application. AIQ is just one component of data quality that also includes
software and analytical method validation, system suitability tests, and quality con-
trol tests. In general, AIQ and analytical method validation generally ensure the
quality of analysis
before
conducting a test; system suitability and quality control
checks ensure the quality of analytical results
immediately before
or
during
sample
analysis.
While method validation and system suitability are covered in detail in Chapters 4,
6, and 7 of this volume, a brief discussion of system suitability and quality control
checks is perhaps necessary here also. System suitability is the checking of a system
to ensure system performance before or during the analysis of unknowns. According
to the USP, system suitability tests are an integral part of chromatographic methods
[8]. These tests are used to verify that the resolution and reproducibility of the system
are adequate for the analysis to be performed. System suitability tests are based on the
concept that the equipment, electronics, analytical operations, and samples constitute
an integral system that can be evaluated as a whole. Parameters such as plate count,
tailing factors, resolution, and reproducibility are determined and compared against
the specifications set for the method. These parameters are measured during the anal-
ysis of a system suitability “sample” that is typically a mixture of main components
and expected by-products.
Quality control check samples are run to make sure the instrument has been prop-
erly calibrated or standardized. Instrument calibration ensures that the instrument
response correlates with the response of the standard or reference material. Quality
control check samples are also often used to provide an in-process assurance of the
test's performance during use.
2.3 AIQ process
Instruments are qualified according to a stepwise process grouped into four
phases: design qualification (DQ), installation qualification (IQ), operational
qualification (OQ), and performance qualification (PQ), as outlined in Table 2.1.
Another way of looking at the AIQ process is sometimes
referred to as a timeline
approach; as presented in Figure 2.1, where a true chronological order of events
takes place.
2.3.1 d
eSIgn
Q
uAlIfIcAtIon
The AIQ process timeline in Figure 2.1 begins with the DQ phase at the vendor's
site, where the instrument is developed, designed, and produced in a validated envi-
ronment according to good laboratory practices (GLP), current good manufacturing
practices (cGMP), and ISO 9000 standards. Users should ensure that the instrument
is fit for their intended use and that the manufacturer has adopted a quality system for
development, manufacturing, and testing, and has adequate support for installation,
