Chemistry Reference
In-Depth Information
and are essential to the production of analytical results that are of high quality and
are compliant with the appropriate regulations.
QC is the process that determines the acceptability or unacceptability of a prod-
uct or a product plan, and is determined by the comparison of a product against the
original specifications that were created before the product existed. In some organi-
zations, the QC group is responsible for the use of the method to perform analysis
of a product. Other tasks related to QC may include documented reviews, calibra-
tions, or additional types of measurable testing (sampling, etc.) and will reoccur
more often than activities associated with quality assurance. QC will usually require
the involvement of those directly associated with the research, design, or production
of a product. For example, in a laboratory-notebook peer-review process, a QC group
would check or monitor the quality of the data, look for transcription errors, check
calculations, verify notebook sign-offs, etc.
QA is determined by top-level policies, procedures, work instructions, and gov-
ernmental regulations. At the beginning of the validation process, QA may provide
guidance for the development or review of validation protocols and other validation
documents. During the analytical stage, QA's job is to ensure that the proper method
or procedure is in use and that the quality of the work meets the guidelines and
regulations. QA can be thought of as the process that will determine the template
and pattern of quality control tasks. As opposed to quality control checks, quality
assurance reports are more likely to be performed by managers, by corporate-level
administrators, or third-party auditors through the review of the quality system,
reports, archiving, training, and qualification of the staff who perform the work.
From a review of the various guidelines, it is evident that AMV is just one part of
the overall validation process that encompasses at least four distinct steps as shown
in Figure 1.2: (1) software validation, (2) hardware (instrumentation) validation/
qualification, (3) analytical method validation, and (4) system suitability. The overall
System
Suitability
Method Validation
Analytical Instrument
Qualification
Software Validation
FIgure 1.2
The basic steps in the validation process.
