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GMP News No. 152
12 December 2001
QualitySystem Inspection Technique
Is the "Quality System Inspection Technique" for the monitoringof medical devices the model of the future for medicinal productsmonitoring, too?
The GMP News of June 22, 2001 presentedthe FDA's pilot program for inspection systems for GMP inspections ofmedicinal products.
The FDA Center for Devices andRadiological Health (CDRH) has already long been using a comparableinspection system for medical devices monitoring. The GMP Rules (QualitySystem Regulations) for the manufacture of medical devices, 21 CFR 820,were amended in the USA as of June 1, 1997. Surprisingly, these amendmentsresulted in far-reaching adjustments to the DIN EN ISO 9000ff standards(QM systems). Consequently, the inspections were also adapted to this"systemic" approach of the new GMP Rules, too.
Since 1999 the program of this"Quality System Inspection Technique" (QSIT) has now beenrevised.
The original inspections concentrated on7 sub-systems (see Fig. 1).
Fig. 1: The sevensub-systems of the Quality System
With the changes in the QSIT the CDRH nowfocuses on four "top" systems:
In order to ensure that the inspectionsare carried out properly, a manual 'Inspection of Medical Devices' hasbeen brought out specially for the inspectors.
Figure 2 shows observations in medicaldevices inspections which refer specially to the four "top"systems.
Fig. 2: QSIT observations
FDA is presently also testing this"systemic" inspection approach in a pilot program in inspectionsin the pharmaceutical sector. Here it concentrates on the followingsystems:
The pilot program provides for twopossible inspection types:
The above leads to two interestinginterpretations
GMP Newsof 30 June 2001