Page 48 - 2023 Taiwan Food and Drug Administration Annual Report
P. 48
2023 Taiwan Food and
Drug Administration
Annual Report
that hold ephedrine but haven’t declare a to PIC/S guides to conduct GMP compliance
manufacturing; this is to avoid the non-medical inspections of western medicinal products
purposes that ephedrine is used for. (including API) manufacturers and to promote
western medicinal products companies to
Section 3 comply with GDP.
Improvement in ▍ Implementation Strategy
Manufacturing
and Distribution I. Supervise medicinal
Management of products manufacturers to
Western Medicinal implement PIC/S GMP
Products
With the advancement of science and
▍ Introduction of the Policy technology, the development of advanced
pharmaceutical technologies, and the
In order to ensure the quality and innovation of quality concepts, international
safety of medicine used by the public, the GMP standards are constantly updated and
Pharmaceutical Affairs Act stipulates that the quality risk management has been introduced.
manufacturers of western medicinal products TFDA continues to revise GMP regulations
should comply with Good Manufacturing referred to the latest GMP standards
Practice (GMP), in order to continuously promulgated by PIC/S and conducts GMP
and steadily manufacture medicinal products inspections based on risk to supervise the
that are consistently in safety, quality, compliance of GMP of manufacturers.
and can achieve expected efficacy. The
Pharmaceutical Affairs Act also stipulates that II. Promote medicinal products
Good Distribution Practice (GDP) should be companies to mplement
implemented for the distribution of western GDP
medicinal products in stages to ensure that
their quality and integrity are maintained Following the completion of GDP
during distribution, storage, and delivery. implementation by Western Pharmaceutical
Currently, the Pharmaceutical Inspection Co- manufacturers, pharmaceutical companies
operation Scheme (PIC/S) GMP and GDP holding the Western Pharmaceutical Product
guides are adopted in our country. TFDA refers licenses, and pharmaceutical companies
engaged in products required cold chain
46 storage and transportation at the end of
2018 and 2021, TFDA further announced
active pharmaceutical ingredients (APIs)
