Page 80 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

1100
Food Medicinal products/ 1046

Cosmetics
1000
Abuse ＧLＰ GLP
900
800 789
Number of Certified Items 481
700

600 637 632 665
500 421 405 536 488
400

300 251 280 280 280 298 370 379
248
200 230
55 58

100 16 19 26 42 49 53

4 7 7 7 7 7 7 9 ＧLＰ 16 ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ 44
0 ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ ＧLＰ 9 9
0 0 0 0 0 0 0 0 9 3 9 9 9 9 9 9
89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 Year
Figure 5-10 Number of TFDA- accredited tests of all years

(2) Enhancing monitoring and supervision systems
A. Regular and unannounced audits
To effectively monitor and manage accredited test laboratories and establish a
system for assessing the truthfulness of test data, in 2016, TFDA audited 147
accredited test laboratories, of which 112 of the audits were first-time audits,
expansion of test items, change of test items, permit extension, and surveillance

audits, while 26 of the audits were unannounced.
B. Implementing proficiency testing
TFDA regularly publishes the results of proficiency testing of accredited
laboratories. In 2016, 25 proficiency tests were carried out, including 17 food
tests and 8 medicinal product and cosmetic tests. TFDA also organized 8
“Laboratory Accreditation Tests Using Double-Blind Samples” in order to verify
the truthfulness of testing data. As the results of proficiency tests of accredited

laboratories, the satisfaction rate of food is 80% when medicinal products and
cosmetics is up to 90%. Additionally, testing laboratories that were accredited for
“food aflatoxin” by TFDA in 2016 must participate in the international proficiency
test which are announced and assigned by TFDA in 2017.

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