Quality System Inspection Technique

GMP News No. 152

GMP News
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:

  • Management Controls
  • Design Controls
  • Corrective and Preventive Actions(CAPA)
  • Production and Process Controls (PAPC)

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:

  • Quality System
  • Facilities and Equipment ManufacturingSystem
  • Material System
  • Production System
  • Packaging and Labeling System
  • Laboratory Control System

The pilot program provides for twopossible inspection types:
The "Full Inspection Option", which is carried out in case ofnew buildings, major changes and after compliance problems (e.g. warningletters). Here the Quality System and three of the other systems areinspected.
In case of companies with a good history of "compliance" thereis the option of a shorter inspection. This inspection option includes the"Quality System" again and another system. In both cases theentire company is considered "out of control" as soon as onesystem is not functioning satisfactorily!

The above leads to two interestinginterpretations

  • Particularly as regards FDA it makessense to pursue developments of various centers - and not"only" the CDER (Center for Drug Evaluation and Research),which is responsible for classical medicinal products - since thesedevelopments can quite well be adopted by other centers.
  • Both in the medical devices sector andin the medicinal products sector inspections are focusing on"Quality Systems" and therefore also on the "QualityUnit" itself.


GMP Newsof 30 June 2001




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