POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 171

equipment, processes, or steps, which have an impact on product quality, should
be reviewed by the quality unit.
7.3.22 Project Close Out
Once the qualification project is complete, the result should be reported to those
individuals responsible for the review and approval of the study results. Com-
missioning and prequalification activities should be complete. The protocol and
report should be complete. Investigations should be closed out. Deviations should
be addressed. Corrective actions should be implemented. Changes should be iden-
tified and documented. All documentation should be available and suitable for
review and approval. Information that is critical to the operation of the equip-
ment and system, including preventive maintenance and operating parameters,
should be transferred to operations and included in the appropriate procedures.
PPQ protocols should reflect any changes in design or process uncovered and
confirmed, during the qualification studies. These changes should be included in
system descriptions and where applicable PPQ test functions, data sheets, and
forms. The result of the qualification and conclusion should be stated. If the con-
clusion is that the equipment is suitable for release to the next step of process
qualification or validation, then this should be clearly articulated.
7.4 CONCLUSION
QRM plays an important role in facility and equipment qualification. Risk assess-
ment techniques can be used to help develop and execute effective facility and
equipment qualification plans. Qualification efforts should be based in part and
commensurate with the effect on product quality, which the facility system or
equipment poses. Risk assessment techniques can be useful in providing informa-
tion needed to make decisions related to which items to qualify, the prioritization
of qualification efforts, setting of useful acceptance criteria, the effective role of
the quality unit, leverage of prequalification and commissioning information, and
the addressing of design changes and study failure.
A risk-based approach to qualification should provide confidence that the
dependent process will perform in a consistent and predictable manner. Having
a strong level of confidence of process performance before commercial manu-
facture commitment is logical, beneficial, as well as compliant. If the study is
designed properly, then qualification failure is an indication that something is
wrong with the equipment and must be corrected. If studies are not designed or
executed properly, then successful completion may not be a complete indication
of successful system installation and function.
It may be true that sometimes qualification appears to be more effort than
necessary. This may be because our industry tends to be overly cautious. On
the other hand, in order for processes to perform to expectations, systems and
equipment must work properly. Inaccurate information, poor design/installation,