Page 88 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

Section 3. Comprehensive Private Laboratory Accreditation and
Management System

To improve testing pro?ciency and quality of local health bureaus and departments, TFDA
established an ef?cient testing specialization system to enhance local testing capacities. TFDA
also initiated an accreditation program of local laboratories and published a list of accredited
laboratories that may be referenced by the general public, helping to conduct testing work
for government agencies, consumer groups, independent quality control organizations within
factories, and product exports and imports.

Current Status
To effectively leverage testing resources of private laboratories, ensure the quality and
credibility of commissioned testing activities, and expand testing capacities, TFDA implemented a
pro-active and free accreditation program for private laboratories. The scope of TFDA laboratory
accreditation include tests for food, drugs, cosmetics, urine tests for identifying drug abuse, and
Good Laboratory Practice (GLP) for non-clinical studies. As of the end of 2015, 163 laboratories
throughout Taiwan were accredited (132 private laboratories and 31 government laboratories),
including 72 food testing laboratories, 30 drug and cosmetic testing laboratories, 15 urine testing
laboratories for identifying drug abuse, and 15 GLP laboratories (Figures 2-7-7 and 2-7-8). As
for regional distribution, there were 88, 29, and 46 accredited laboratories in northern, central,
and southern Taiwan respectively. 1,221 tests items were accredited, of which 789 were related
to food, 370 to drugs and cosmetics, nine to urine tests for identifying drug abuse, and 53 GLP-
related tests items (Figure 2-7-9). The accreditation program helped to establish laboratories with
adequate testing capacity and credibility able to meet testing requirements for emergencies and
sudden events.

Policies and results
1. Accreditation of Food, Drugs, and Cosmetics Laboratories
(1) Expanding Testing Capacities of Laboratories
a. Accreditation programs for food laboratories as well as drug and cosmetic laboratories were
initiated in 2004 and 2008 respectively. In 2010, TFDA streamlined and expanded the laboratory
accreditation action plan and continued to promote border inspections for food and traditional
Chinese medicine, establish quantity limit standards for traditional Chinese medicine, and
provide accreditation to commissioned tests for administrative processes in order to accelerate
the expansion of testing capacities.
b. As of 2015, the numbers of accredited laboratories and tests were increased to 102 laboratories
and 1,159 tests items respectively, with 51, 18, and 33 laboratories in northern, central, and
southern Taiwan respectively. 72 of these were food testing laboratories while 30 were drug and
cosmetic testing laboratories (Figures 2-7-7 to 2-7-9).
(2) Enhancing Monitoring and Supervision Systems

a. Regular and Unannounced Audits
To effectively monitor and manage accredited test agencies and establish a system for assessing
the truthfulness of test data, TFDA audited 133 accredited test agencies, of which 112 of the
audits were ?rst-time audits, expansion of test items, change of test items, permit extension, and
surveillance audits, while 21 of the audits were unannounced.

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