Biomedical Engineering Reference
In-Depth Information
that alleges defi ciencies related to the identity, quality,
durability, reliability, safety, effectiveness, or performance of
a [product] after it is released for distribution.”
27
Processing
of complaints and maintaining complaint fi les is an FDA
requirement for many of the areas under its jurisdiction, as
displayed in Table 1.7.
Upon receiving a complaint, CQU conducts a triage
whereby the complaint is classifi ed according to type: routine
complaint or urgent complaint. If the complaint is classifi ed
as routine, a response is prepared, routed via the QMS
through the approval process and fi nalized, and the fi le is
closed. No operational SOPs would be revised as a result of
a routine complaint. If the complaint is classifi ed as urgent, a
record is opened in the QMS, the complaint is classifi ed in
terms of product quality complaint (PQC) criteria, and the
complaint and supporting material are routed to the
manufacturing site.
Management decides whether an investigation is required;
if so, a responsible person is assigned the task of preparing
an investigation plan, and a time schedule is developed.
Preliminary tests are conducted, such as X-ray, visual
inspection, and functional tests. If further investigation is
Table 1.7
FDA predicate rules for complaint fi les
Regulated Area
Regulation
GCP
21 CFR 310
GMP
21 CFR 211.198
GTP
21 CFR 864.3250; §1271.320
HAACP
21 CFR 123.8
Mammography
21 CFR 900.4
Medical Devices
21 CFR 814.9; §820.198
Medicated Feeds
21 CFR 225.115
