Biomedical Engineering Reference
In-Depth Information
Fig. 5
Process knowledge repositories and the flow of information during process execution
''process fitness'' on the manufacturing floor. After a successful validation exer-
cise, BPRs are created to capture process execution data.
Engineering groups in an organization are involved in ensuring that utilities
(air, gases and water) that are supplied and the process equipment that is used are
fit to execute the process. To achieve this goal, engineering teams maintain
metrology records and maintenance logs/schedules for all the equipment and
instruments used during process execution.
The facility management group ensures that the clean-room environment is
maintained according to cGMP standards and that the batch is not jeopardized due
to contamination issues. This group also maintains a cleaning log/schedule for all
the clean rooms used during the process execution.
Test samples are regularly collected to check for in-process controls, and these
are sent to an internal quality control laboratory for testing. The test results are
compared against the specification limits set in the process development tech-
nology transfer reports. Any out of specification (OOS) or deviations are reported
to the execution and quality assurance teams.
The manufacturing team investigates all batch OOS, non-conformances and
deviations observed during the process execution. Such root cause investigation
draws upon information captured at all stages by various groups (process develop-
ment, engineering, facility, quality) as shown in Fig.
6
. The corrective and preven-
tative actions derived from these investigation reports form the basis of process
change control. The change control system is logged and maintained by the quality
assurance group, which then feeds information for improvement initiatives back into
various systems across various functional groups as shown in Fig.
6
.
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