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Food and Drug Administration

88

Policies and Outcomes

1. Accreditation for Food as well as Drugs and Cosmetics Laboratories

(1) Expanding Laboratory Testing Capabilities

a. Accreditation systems for food laboratories and drugs and cosmetics laboratories were initiated in

2004 and 2008 respectively. In 2010, laboratory accreditation action plans were further expanded

and accelerated to quickly increase testing capabilities through continued implementation of border

inspections of food and Traditional Chinese Medicine (TCM) products, establishment of standard

limits for TCM, and accreditation of test items outsourced by administrative processes.

b. The number of accredited laboratories and tests increased from 36 laboratories and 353 tests in

2009 to 91 laboratories and 1,153 tests in 2014. These laboratories included 61 accredited food

testing laboratories and 30 accredited drugs and cosmetics testing laboratories with 48, 13, and 30

laboratories in northern, central, and southern Taiwan respectively.

(2) Strengthened Supervision and Management Systems

a. Regular and Unannounced Audits

To effectively supervise and manage accredited laboratories and to establish a system for verifying

the reliability of test data, TFDA performed a total of 108 audits, of which 88 were first-time audits,

audits for increases or changes in testing scope, extension audits, and surveillance audits as well

as 20 unannounced audits.

b. Organizing Proficiency Tests

Proficiency test results of various accredited laboratories are publicly released on a regular basis.

In 2014, a total of 26 proficiency tests (20 for food and 6 for drugs and cosmetics) were held. Of

which, 2 laboratories had their accreditation revoked for failure to meet proficiency test standards.

A total of 4

Laboratory Accreditation Test Using Double-Blind Samples

were also used to verify the

correctness of test data.

Figure 8-7

Number of accredited tests over time

7

7

7

7

7

7

9

9

9

9

9

9

9

9

525

488

517

248

230

55

16

39

58 56

20

17

41

3

280

280 280 298

421

481

637

600

665

0

100

200

300

400

500

600

700

GLP

GLP

GLP

GLP

GLP

GLP

GLP

GLP

GLP

GLP

GLP

GLP

GLP GLP

GLP

Foods

Drug Abuse

GLP

Drugs

and Cosmetics

Year

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Accredited laboratories