POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 155

Once the impact assessments are completed, the information can be used
to develop the specific commissioning and qualification plans. Systems or
components that have a direct impact will likely require qualification and quality
unit oversight/acceptance criteria approval. Systems or components that have
an indirect impact may require qualification depending on the level of impact.
Systems or components that have no impact on product quality may not require
qualification. All systems may require commissioning to assure proper function.
However, the commissioning of direct and indirect impact systems may require
additional levels of control and quality unit review, if that information is to be
leveraged as part of the qualification effort.
It is important to note that the information obtained from the impact assess-
ments may also be considered when entered into the maintenance program and
change control/change management procedure. The impact items have on product
quality should be considered when addressing the response to process, system,
or procedural changes. Noncritical components on a critical system would not
need to undergo qualification. A simple work order might suffice. However, if a
new piece of equipment or component was added to a system or removed, then
the assessment would need to be revised. This is a much more time-effective
activity than qualification.
Table 7.3 presents an example of an impact assessment. The answers to the
following questions will determine if a system is direct, indirect, or no impact.
An affirmative answer to questions #1 through #6 generally indicates that the
system is direct impact. An affirmative answer to only question #7 generally
indicates that the system is indirect impact. If the answer to each question is
negative, then the system may be deemed no impact.

TABLE 7.3 System Assessment
Direct Impact System Assessment Criteria

Yes/No

1 Does the system have direct contact with the product? No

2 Does the system produce or have direct contact with raw material,

excipient, or solvent that comes in contact with the product?

No

3 Is the system used in cleaning or sanitizing production equipment or

systems?

No

4 Does the system preserve product status (physical, chemical or

microbiological integrity)?

Ye s

5 Does the system produce data that is used to accept or reject product,

medical devices, or stability data that will be used to make future
quality or regulatory decisions?

Ye s

6 Is the system a process control system that may affect product

quality and there is no system for independent verification of
control system performance in place?

No

7 Does the system supply a utility or function to a direct impact system

or otherwise affect the performance of a direct impact system?

Ye s