GMP News No. 152
12 December 2001
Quality System Inspection Technique
Is the "Quality System Inspection Technique" for the monitoring of medical devices the model of the future for medicinal products monitoring, too?
The GMP News of June 22, 2001 presented the FDA's pilot program for inspection systems for GMP inspections of medicinal products.
The FDA Center for Devices and Radiological Health (CDRH) has already long been using a comparable inspection system for medical devices monitoring. The GMP Rules (Quality System Regulations) for the manufacture of medical devices, 21 CFR 820, were amended in the USA as of June 1, 1997. Surprisingly, these amendments resulted 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 been revised.
The original inspections concentrated on 7 sub-systems (see Fig. 1).
Fig. 1: The seven sub-systems of the Quality System
With the changes in the QSIT the CDRH now focuses on four "top" systems:
In order to ensure that the inspections are carried out properly, a manual 'Inspection of Medical Devices' has been brought out specially for the inspectors.
Figure 2 shows observations in medical devices 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 inspections in the pharmaceutical sector. Here it concentrates on the following systems:
The pilot program provides for two
possible inspection types:
The above leads to two interesting interpretations
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