Page 56 - 2018食藥署年報(英文版)

Implementation Measures

1. PIC/S Committee Meeting

A 2-day PIC/S Committee Meeting was convened between September 11-12, 2017,
discussing long-term developing road map (e.g. strategies and projects for harmonizing the GMP
regulations and enhancing the international collaboration, including reviewing the progress
of work plans on revising the standard, global inspector training, etc.) and short- to mid-term
assignments and progress. During this meeting, the Chairperson, Deputy Chairperson, and Chairs
of Sub-Committees of PIC/S in 2018-2019 were also elected. The representatives of TFDA were
also candidates of positions of PIC/S Sub-Committee, to actively participate in PIC/S affairs and

events, consolidate Taiwan’s membership, increase our international visibility and explore more
substantial collaboration opportunities with other competent authorities from other countries
through PIC/S platform.

2. PIC/S annual seminar

PIC/S Annual Seminar was then hosted between September 13-15, 2017 (Figure 3-5),
which was the grandest annual gathering of PIC/S that brings together global GMP inspectors

to discuss pharmaceutical GMP-related topics every year. The theme of 2017 was “Quality
Control Laboratories: How to Inspect.” Quality Control is part of GMP which is concerned with
sampling procedures, specifications, testing methods and release to ensuring that the necessary
and relevant tests are actually carried out and materials and products will only be released for use
and supply until their quality has been judged to be satisfactory. Discussions involve “the latest
GMP requirements,” “out-of-specification (OOS) and out-of-trend (OOT) investigation,” “data
integrity,” “technical transfer of test methods,” and “inspection skill of quality control laboratories
at pharmaceutical manufacturers.” Through keynote speeches given by experts from the US,
UK, France, Australia, Canada, Japan and Taiwan and workshops discussions with participants,

a more complete quality standard, improving inspection regulations and skills to ensure the
integrity, authenticity, reliability and traceability of the data, effectively supervise quality control
laboratories of pharmaceutical manufacturers, and eventually achieve the goal of public benefit.

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