Biomedical Engineering Reference
In-Depth Information
or failure of the equipment performing the mixing process would likely have an
adverse effect on the strength and therefore effectiveness of the product, as it
could cause nonuniformity of active ingredient or solubility issues. This failure
could be a result of improper mixer design, impeller sizing, positioning, or speed
variation. Likewise, failure of the cleaning or sterilization systems could be the
result of clean-in-place pumps malfunction, improper line sloping, and so on. On
the basis of this analysis, both mixing and cleaning are process steps that should
be qualified. Further, the equipment and systems installed to control these steps
should be qualified.
It is essential to understand the relationship between product quality—the
process steps that can adversely affect quality—and the facility conditions and
equipment that affect or perform those process steps. Item 5 is facility lighting.
Can lighting affect product quality? It depends on what the lighting is used for. If
it is used for illuminating a process floor—perhaps, but the effect would not be
direct. What if the lighting was used to illuminate an inspection box where filled
vials are inspected by visual observation? What if the product is light sensitive?
7.3.3 Linking Product Quality Risk to Qualification Testing
Deciding on items and systems to test as part of risked-based qualification follows
a logical and sequential approach. The approach can help identify the elements
of a process that can adversely affect product quality and choose test methods to
confirm that those elements are properly functioning and controlled. Figure 7.4
presents a simple example using an aseptic process. The sequence starts with
identifying the critical quality attributes (CQAs) of the product. The CQAs are
those elements or characteristics of the product that define it for commercial use.
Columns 1 and 2 list the CQA categories and the attributes that define the product
as safe, effective, pure, and identifiable. Column 3 lists the corresponding process
steps that can have an adverse effect on those CQAs. Column 4 lists the systems
that support those steps. Column 5 lists the function that the system performs.
Once this is understood, the next step, as presented in column 6, would be
to determine test functions and acceptance criteria for demonstrating that those
functions occur on a consistent and reliable basis. These tests may also include
documentation of proper design and installation. In this way, a link has been
created from the qualification test back to a particular CQA. This assures that
qualification tests are performed on systems where there may be an affect or risk
to the product.
7.3.4
Impact Assessment: Deciding What to Qualify
One method for determining what to qualify is to use a system impact assess-
ment. An impact assessment is a form of risk assessment, where the impact of
the function of a system, piece of equipment, or facility condition on product
quality is determined. It is a method of determining whether a system or system
component requires qualification or to what extent it should be qualified. This
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