POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 153

issues are not addressed. However, it is worth mentioning that it would be logical
to consider inclusion of these systems in the qualification program.
In any case, an impact assessment could provide information that will guide
decisions related to the design of the qualification study, including the extent of
qualification. Equipment systems could be categorized as having direct impact,
indirect impact, or no impact on product quality. To that end, basic impact assess-
ment guidance questions might include the following:
• Does the system or component contact the product or a material that contacts
the product?
• Does the system or component control or maintain a critical environment?
• Does the system or component control or measure a parameter or condition
that can affect product quality?
• Will the failure of the system or component affect product quality?
7.3.5 System- and Component-Level Impact Assessments
System- and component-level impact assessments are critical to the risk manage-
ment strategy. Not all systems require qualification and not all components require
qualification. The basis of this program requires an accurate system and compo-
nent list. This can be a challenge because complete system lists are sometimes
difficult to find early in the project and accurately maintain.
The initial system list may be a result of previous engineering activities and
thus be documented in an engineering design review report. Equipment and com-
ponents may be obtained by review of approved P&IDs, design-related equipment
lists, or process descriptions. There should be a system in place to accurately
identify when the P&IDs are updated with additions or deletions of systems.
Components of systems may also be obtained by review of material requisitions,
which is also labor intensive.
Subsequent to the initial documentation of the systems and components, these
lists need to be managed as living documents and therefore controlled as part
of the construction and/or engineering change control program. Changes may
and likely will occur during construction. The change control programs must
accurately contain information necessary to complete impact assessments, be
easily located, and contain a trigger to revise impact assessments.
7.3.6 System Impact Assessments
A good system impact assessment approach starts by defining different levels
or classifications of impact. These might include GMP critical (direct impact),
cGMP noncritical (indirect impact), and no impact. The approach should include
a series of questions that will help determine the systems classification. This
is best completed during a risk assessment review session with stakeholders
having information that could contribute to the decision to classify the system.