Page 44 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

(2) Complete compliance to the PIC/S GMP by modern pharmaceutical manufacturers
A. Taiwan formally became a member of the PIC/S organization since 2013, ahead
of Japan and South Korea, which proved that GMP management and auditing
practices of pharmaceutical companies in Taiwan have been successfully
aligned to international standards. To improve the quality of pharmaceutical
manufacturing, TFDA took active measures in strengthening pharmaceutical
production quality and ensure the safety of medicinal products for the public
by enforcing complete compliance to PIC/S GMP in all domestic and imported
western pharmaceutical manufacturers in 2016.

B. Follow-up management for modern pharmaceutical manufacturers includes
routine and non-periodic inspections. Unannounced site inspections were
also carried out for specific incidents (such as whistle-blowing incidents,
nonconforming products identified during post-market quality surveillances, and
news events). Theme-based audits were also initiated to further verify the current
status of quality management in modern pharmaceutical companies. On-site

sampling and testing were conducted as part of the quality monitoring process to
ensure that quality of medicinal products is maintained within the stated period
of expiry.

C. At the end of December 2016, a total of 127 modern pharmaceutical

manufacturers in Taiwan are compliant with PIC/S GMP standards (Table 3-1)
and 936 overseas modern pharmaceutical manufacturers of imported medicinal
products have been assessed as compliant. Also, by the end of December 2016,
a total of 268 foreign modern pharmaceutical manufacturers have passed on-site
inspections, ensuring a stable market supply of medicinal products of all dosage
forms.

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