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(3) In 2014, TFDA convened the
Drug Abuse Urine Testing Institution Accreditation Review Committee
and On-Site Assessment Committee Meeting
, and the Conference for Drug Abuse Testing Techniques.
Main resolutions included: delaying additional and extension audits payment systems; one institution
was accredited; in the event that the testing institution needs to add a branch institution or office for
temporary storage of remaining urine samples, the said institution must first submit an application to
TFDA for review and verification before completing the registration.
3. Good Laboratory Practice (GLP) Accreditation for Non-Clinical Studies
(1)
Good Laboratory Practice (GLP) for non-clinical studies
is implemented in order to improve the
correctness and reliability of test data. The scope of GLP accreditation of TFDA includes the fields of
medicinal products, medical devices, health foods, and cosmetics, and covers various non-clinical
safety tests related to biological systems at various product research and development phases in the
aforementioned fields.
(2) In 2014, TFDA conducted and offered eight GLP audits and consultation, reaching a total of 17 GLP-
accredited laboratories with 14 in northern Taiwan and three in central Taiwan. Of these, 56 testing
items were accredited accordingly.
(3) In 2014, auditor training and business owner management seminars were also held in order
to introduce the latest information from other countries, align audit standards with international
specifications, and help business owners and relevant personnel understand GLP specifications and
industrial trends.
Section 4 Comprehensive Mobilization for Emergency Testing
Current Status
TFDA formulated the
Principles for Mobilizing Private Laboratories in Response to Emergencies
. To meet
testing requirements arising from emergencies, private laboratories with the relevant testing equipment
and capabilities may be mobilized to participate in testing work, allowing the emergency response
system to serve as the basis for post-market testing of products as well as self management and testing
by business owners.
Policies and Outcomes
1. Selection Principles for the List of Accredited Laboratories
Laboratories accredited for
specified tests and methods
or other accredited laboratories certified by
the Environmental Protection Administration (EPA) or Taiwan Accreditation Foundation (TAF).
National
Inspection Resource Database
of the TFDA is also used to survey private agencies equipped with
these testing instruments and invite these agencies to help carry out the specified tests.
2. Verifying Laboratory Testing Capabilities and Public Release of the List of
Accredited Laboratories
TFDA has provided laboratories with testing methods as the basis so that the laboratories would only
need to refer to the standard operation procedures (SOP) and maintain quality assurance documents
and relevant test records. Applicant laboratories that have been verified to have the necessary
testing techniques and independent quality control capacities are included in the list of accredited
laboratories, which is publicly released by the TFDA for reference by those intending to commission
testing services.