Biomedical Engineering Reference
In-Depth Information
7.1.5 Qualification and Risk Management
There are key questions to consider when developing a risk-based qualification
approach.
1. Which items should be qualified?
2. What is the correlation between system function and product quality or
patient safety?
3. What are the acceptance criteria or information needed to qualify those
items?
4. What is the source of that information?
5. How will information or results be evaluated?
Quality risk management (QRM) can be a method for providing information
needed to help answer those questions. QRM can also be used to prioritize and
focus commensurate efforts on commissioning and qualifying those things, sys-
tems, and processes that, if they fail, could have an adverse affect on product
quality, specifically to the point of adversely affecting patient safety. Patient
safety is directly related to product quality. However, these terms are not syn-
onymous. System failures will result in loss of product quality, but if that failure
is detected or that product rejected before reaching the patient it will not cause
harm. On the other hand, disruption of product supply as a result of system failure
may adversely affect patient safety without affecting quality of product.
The pharmaceutical and biopharmaceutical industry has recognized the value
of QRM in the planning and performance of qualification activities. Figure 7.3
shows the results from a 2006 PDA survey of 129 companies. The response to
the question: “From a theoretical risk management perspective, what functional
area has the most need for risk assessment” indicated that companies felt that
Aseptic processing/filling
Sterilization
Qualification/validation activities
Facilities
Quality control (laboratories)
Technical transfer activities
Formulation
Packaging & inspection
Labeling
Purchasing
Distribution
Other
0
1
2
3
4
5
6
7
8
9
10
11
Average response
Figure 7.3 2006 Parenteral Drug Association survey on the functional area that has the
most need for risk assessments. ( See insert for color representation of the figure .)
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