POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 149

However, compliance with regulatory expectations should not be the only
reason to plan and perform qualification programs. The overall objective of a
qualification program should be to create a robust and reliable process which
assures that the process is capable of manufacturing a product that meets the
company's requirements for product quality. Companies can make costly mis-
takes when planning and conducting commissioning and qualification of a facility
by qualifying beyond what is necessary to mitigate risk to product quality or by
not adequately qualifying systems that may pose a risk to product quality. They
may choose to include systems and efforts that are redundant and unnecessary.
Limited time and resources may then result in the potential to overlook or not
adequately qualify items that should be included in the qualification. An approach
based on relative risk to product quality can help a company prepare an optimal
plan that will be effective, efficient, and compliant.

7.3.2 Define which Items to Qualify

To understand the role of risk assessment in qualification, it is helpful to note that
risk and uncertainty are directly related. The less certain something is, the more
risky it is. Qualification can reduce uncertainty by providing assurance of system
function reliability and appropriateness of design in relation to process outcome.
As such, qualification is a means of reducing risk. However, effective qualifi-
cation approaches rely on an understanding of the correlation between system
function and process outcome. Without that correlation, it is difficult to design
an effective means to test and challenge the function. The correlation between
the process step failure and product quality should be defined. Table 7.2 presents
a simple correlation analysis between process steps and the quality attributes they
affect.
Table 7.2 illustrates the correlation between process steps, associated equip-
ment, and product quality attributes. In this example, failure of the mixing process

TABLE 7.2 Correlation between Process Step and Quality Attribute

Product quality/patient safety

Process step/operation

Mixing Efficacy, strength

1.

Cleaning & sterilization Purity, safety

2.

Labeling & coding Identity

3.

4.

Stability testing Efficacy, strength, safety

Lighting Strength, identity, purity

5.