Biomedical Engineering Reference
In-Depth Information
regulated areas, including good laboratory practice (GLP),
GMP, blood processing, medical devices, and tissue
processing. The agency also requires written procedures for
calibration, and documentation of the calibrations ( Table 3.4 ).
The process of calibrating equipment or instruments
involves measurement standards, the calibration process
itself, and the device. Measurement standards include the
Table 3.4
FDA predicate rules for calibration
Regulation
Calibration Predicate
Rule
SOP Predicate Rule
21CFR58.63
(a) Equipment used for
the generation,
measurement, or
assessment of data shall
be adequately tested,
calibrated and/or
standardized.
(b) written standard
operating procedures
[. . .] shall set forth in
suffi cient detail the
methods, materials,
and schedules to be
used.
21CFR211.68
(a) Equipment [. . .] shall
be routinely calibrated.
[. . .] according to a
written program
designed to assure
proper performance.
21CFR211.160;
§ 211.194
(b) Laboratory controls
shall include: (4) The
calibration of
instruments, apparatus,
gauges, and recording
devices at suitable
intervals.
[. . .] in accordance
with an established
written program.
21CFR606.60;
§ 606.160.
(a) Equipment used in
the collection,
processing, compatibility
testing, storage, and
distribution of blood and
blood components shall
be [. . .] calibrated on a
regularly scheduled
basis.
(b) Records shall be
maintained that
include, but are not
limited to, the
following when
applicable: (5) Quality
control records: (i)
Calibration and
standardization of
equipment.
(
Continued
)
