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2015 Annual Report

29

Controlled

Drugs

Management

Medical

Devices

Management

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

Medicinal

Products

Management

Policy and

Organization

Food

Management

GMP

cGMP(current GMP)

Validations

PIC/S GMP

Japan visit and observations

by the Department of

Health and drafting of the

GMP outlines

Release of the

Pharmaceutical

GMP

1977

1982 1988 1995 1999 2005 December

2007

January

2010

Since 31 December

2014

Complete implementation

of the GMP

Complete implementation

of 3 validation stages

Validations of sterile

products

Public announcement of

implementing validation

to all

manufacturers/products

Public announcement of

PIC/S GMP implementation

Schedule

Promulgated PIC/S GMP

Complete implementation

of PIC/S GMP

An overview on the management scope of Taiwan's pharmaceutical GMP system shows that

the system started from modern pharmaceutical manufacturers and gradually incorporated

pharmaceutical distributors, medicinal gases manufacturers, and API manufacturers. In the

future, pharmaceutical Good Distribution Practice (GDP) will also be promoted and implemented

to ensure that quality management covers the entire pharmaceutical supply chain. To achieve

medicinal products source management and safeguard public safety in drug use, TFDA must

ensure conformance of PIC/S GMP amongst all modern pharmaceutical manufacturers, improve

pharmaceutical quality management of the manufacturers, and strengthen internal and external

supervision of the manufacturers.

Policies and Outcomes

1. Complete Compliance to the PIC/S GMP byModern Pharmaceutical Manufacturers

(1) Promotion of PIC/S GMP

a. In 1 January 2013, ahead of Japan and South Korea, Taiwan became an official member of

PIC/S, demonstrating international acceptance of the regulations, adminstration systems, and

inspection standards of pharmaceutical manufacturers in Taiwan. In 31 December 2014, TFDA

has successfully ensured that all modern pharmaceutical manufacturers have successfully

implemented the PIC/S GMP and fully comply with its requirements in order to continuously

safeguard drug use safety of the general public.

b. To continuously enforce stringent monitoring of medicinal products manufacturing, in addition

to conducting routine inspection of manufacturing sites every two-to-three years, unannounced

on-site inspections will be carried out in response to special incidents (such as whistle-blowing

events, post-market quality surveillance anomalies, and news events). For-cause inspection

plans must be used to verify whether the manufacturing sites are carrying out continuous

monitoring of medicinal product quality, by conducting on-site inspections and product sampling

as part of the quality monitoring measures to ensure that medicinal products quality within shelf

life are maintained.

Figure 3-5

History of implementing GMP amongst modern pharmaceutical manufacturers