Biomedical Engineering Reference
In-Depth Information
to a new area with less personnel traffi c, placement of the
balance on a stand-alone low vibration table, and installation
of a protective enclosure around the balance pan to restrict
air drafts. Use of the new protective shield required a revision
of the weighing procedure. Training in the use of the weighing
procedure was also required.
An important implication of these changes was the
necessity of revising SOPs, including the calibration and the
weighing procedures. The next session highlights the factors
included in the revision of the calibration SOP and the critical
review of this revision.
3.4.3 Critical review of the calibration SOP
A manufacturing or lab system in a regulated framework
must be demonstrably in control. Any piece of equipment
that is part of that system must function according to
standards. Because of normal wear and tear, the equipment
will tend to deviate from those standards. Equipment
calibration and preventive maintenance programs are the
method to maintain acceptable equipment performance.
As seen in the CAPA plan, the criticality of the weighing
procedure necessitated a review of the balance calibration
requirements, standards, and guidance.
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The requirements
included FDA predicate rules for calibration and the
documentation of calibration activities, and internationally
recognized standards for calibration. The guidance included
FDA recommendations for a calibration SOP, and the
directions to be gleaned from FDA inspectional observations
and warning letters addressing the failure to meet these
requirements, standards, and procedures.
Among regulatory documents supporting calibration, FDA
requires calibration of equipment and instruments for all
