Quality System Inspection Technique

GMP News No. 152

GMP News
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:

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

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:

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

The pilot program provides for two possible inspection types:
The "Full Inspection Option", which is carried out in case of new buildings, major changes and after compliance problems (e.g. warning letters). Here the Quality System and three of the other systems are inspected.
In case of companies with a good history of "compliance" there is the option of a shorter inspection. This inspection option includes the "Quality System" again and another system. In both cases the entire company is considered "out of control" as soon as one system is not functioning satisfactorily!

The above leads to two interesting interpretations

  • Particularly as regards FDA it makes sense 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 these developments can quite well be adopted by other centers.
  • Both in the medical devices sector and in the medicinal products sector inspections are focusing on "Quality Systems" and therefore also on the "Quality Unit" itself.
  • Would you like more information?

    If you are especially interested in pharmaceutical quality systems, we can offer you the following event:

    FDA and GMP Compliance in Quality Assurance Units, 21-22 February 2002, Barcelona


    GMP News of 30 June 2001


    Sven Pommeranz, CONCEPT HEIDELBERG

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