Biomedical Engineering Reference
In-Depth Information
1.5 Intervention due to external
observation
There are three major occasions for intervention that may
result from an external observation of a deviation and,
therefore, may lead to the revision of an operational SOP.
The fi rst is an observation made by an investigator during a
regulatory inspection.
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The second is an observation
associated with an AE. The third is an observation that
accompanies a customer quality complaint.
1.5.1 Regulatory inspection
FDA has defi ned “an establishment inspection [as] a careful,
critical, offi cial examination of a facility to determine its
compliance with laws administered by FDA.”
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More specifi cally, the inspection examines the organization's
adherence to the concepts of sanitation and GMPs,
seeks assurance that all reasonable precautions are
being taken to ensure the SISPQ of fi nished products, and
seeks to identify defi ciencies as well as to obtain correction
of those defi ciencies. This inspection can be either
comprehensive or directed. The comprehensive inspection
covers everything in the organization subject to FDA
jurisdiction to determine the organization's compliance
status. The directed inspection covers specifi c areas to an
assigned depth (
ibid
.).
In the case of a manufacturing site, this inspection will
typically inspect the quality system and one of the other fi ve
systems of the FDA Quality Systems Approach: facilities and
equipment, laboratory controls, production, packaging and
labeling, and materials.
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A regulatory inspection can include
FDA personnel reviewing records of prior inspections,
