Page 66 - 2018食藥署年報(英文版)

Section 2 New Constructions and Renovations of

Pharmaceutical Manufacturing Facilities for
Controlled Drugs

Origin of Policy

Existing manufacturing facilities where controlled drugs are manufactured of the
Administration have been in use since 1988. The obsolete premises and equipment and also space

is no longer sufficient for use. In order to meet international PIC/S GMP regulations and increase
production lines and productivity that help prevent against risk of shortage in Class 1 and Class
2 controlled drugs and also to take into consideration the need for increasing the R&D space to
add items to be manufactured and to increase the local production rate, the Administration raised
NTD 494 million for the Controlled Drug Manufacturing Premises Construction and Renovation
Project that started in 2012 and would be completed in March 2019.

Implementation Measures

In order to build such a national manufacturing facility, during as early as the planning stage,
expertise of the Administration in PIC/S GMP, medicinal product manufacturing regulations,
professional process equipment and requirements for the clean area and the expertise of the

handling agency, that is, the Construction and Planning Agency in building and spatial design,
have combined the review of construction devices, greening and energy-saving, smart buildings,
among others. Meanwhile, we worked closely with design, construction surveillance, earthwork,
air-conditioning, and water system service providers so that the project could be completed as
scheduled in July 2017 (Figure 4-1).

Outcomes and Benefits

Respective systems, pharmaceutical equipment, and machines are being qualified in the

newly built facility at the moment. Once the whole building is completed and the whole facility
is PIC/S GMP certified, it is expected that the total area of all premises, old and new, of the
manufacturing facility for controlled drugs, will increase by 2.3 folds; the number of production
lines for injections and tablets will increase from 1 to 2. There will be reserved room for the
R&D and production of oral solutions and patches to be added if needed. Production items may
be expanded and added and productivity will be enhanced to ensure steady supplies of such
medicinal products that are needed during wartime and in case of emergency. In addition, this new
manufacturing facility was awarded “excellent” in the Public Construction Gold Award (Figure
4-2) and also the first project of the Ministry of Health and Welfare to win that award.

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