Page 83 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 5. Testing Technology and Capability

3. Good laboratory practice (GLP) laboratory accreditation for Non-

clinical studies
(1) TFDA implemented the GLP for Non-clinical Studies in order to improve the
truthfulness and reliability of test data. The scope of TFDA GLP accreditation
includes the sectors of medicinal products, medical devices, health foods, and

cosmetics, as well as relevant non-clinical safety tests for biological systems during
the research and development (R&D) phase of the various sectors.

(2) In 2016, TFDA completed GLP audits and consultations for 12 laboratories and
accredited 15 GLP laboratories and 44 tests items, of which 13 and 2 laboratories
were in northern and central Taiwan respectively.

(3) Considering animal welfare and 3R principles (replacement, reduction and
refinement), TFDA added new accredited replacement items and met the future

international trends.

(4) In 2016, TFDA implemented auditor training and business management seminars,
and introduced the latest information from other countries to establish consistent
auditing standards as well as trends in the industry.

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