Biomedical Engineering Reference
In-Depth Information
Requalification can range from complete data analysis to selected testing to
full qualification. It can be triggered if an event occurs, putting in question the
qualification of the system. Such events may include the following:
• changes in equipment or process;
• changes in components or materials run on equipment;
• changes in use of equipment;
• repeated failures;
• changes in procedures; and
• changes in regulatory expectations or requirements.
Requalification can also be performed on a periodic basis. The FDA process
validation guidance addresses periodic reevaluation of qualification by stating
that: “Maintenance of the facility, utilities, and equipment is another important
aspect of ensuring that a process remains in control. Once established, qual-
ification status must be maintained through routine monitoring, maintenance,
and calibration procedures and schedules (21 CFR part 211, subparts C and D).
The equipment and facility qualification data should be assessed periodically to
determine whether requalification should be performed and the extent of that
requalification. Maintenance and calibration frequency should be adjusted on the
basis of feedback from these activities [17].” A reason for periodic requalifi-
cation would be that the complexity of systems does not allow for complete
knowledge of all changes, effects of wear, and unknown occurrences that may
cause variations in performance.
Risk assessments and evaluations can be used to address the need for and
extent of requalification. Factors that need to be considered are as follows:
• robustness or reliability of processes or systems;
• experience with systems;
• redundancy in process and system controls; and
• potential impact of system failure on product quality and patient safety.
Written procedures should be in place to address evaluation, decision criteria,
justification, and requalification methodology and schedule.
7.3.19 Performance Qualification: Contamination Control
Product contamination represents a notable risk to product quality. Contamination
from microorganisms and other foreign substances is often difficult to detect and
may result in considerable harm to the patient. Contamination control process
steps such as cleaning, disinfection, sanitization, sterilization, and holding of
sterilized materials are almost always deemed as critical and direct impact. Risk
assessment techniques can be used to help determine worst case configurations
and conditions to be qualified and areas and items that are most difficult to clean
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