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
References:
GMP News
of 30 June 2001
http://www.fda.gov/cdrh/gmp/gmp.html
Writer:
Sven Pommeranz, CONCEPT HEIDELBERG
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