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(2) TFDA organized GLP annual audit personnel training and education course in 2013,
and introduced the latest international information in real-time so that audit standards
are conforming internationally.
Section 3 Mobilization for Emergency
Status
In response to emergency testing demands, TFDA mobilizes private laboratories with
relevant testing equipment and capability to participate in the testing work, and through
emergency response mechanism assists self-management inspection of commercial
products and industry. To regulate the published private laboratories, as well as to
ensure their test quality, on August 4, 2011 the
“
Operational directives in response to
mobilizing private laboratories in emergency operations
”
was set up to be followed when
facing relevant operations for a large number of required tests.
Policy and Outcome
1. In Response to Emergencies, TFDA Formulates the Participation and
Testing Process for Accredited Private Laboratories.
2. Achievements of Emergency Inspection Mobilization
(1) Laboratory list and inspection force
In response to the large number of test requirements, the
“
National Inspection
Resource Database
”
which was set up by TFDA has investigated whether private
laboratories possessing testing instruments were willing to participate and their
testing capacities. The private laboratory mobilization achievements, such as
plasticizers, maleic anhydride chemically modified starch and oil incidents, in
response to emergencies in 2011-2013 as shown in Fig. 8-5.
(
2) Quality control of laboratory testing management
In response to emergencies, TFDA published list of laboratories, in addition to
reviewing document, on-site inspection and proficiency tests were also organized
and implemented. If the results of on-site inspection or proficiency tests are not
satisfactory during the corrective period, if necessary,
“
Outside sample acceptance
by laboratory for the test will be stopped
”
.