GMP
IN AUSTRALIA . . .
In Australia, all vitamins, herbal products, and
some essential oils are classified as THERAPEUTIC GOODS, along with
ethical pharmaceutical products. These products must all be made to
a similar standard of manufacture - in compliance with the Australian
Code of Good Manufacturing Practice for Medicinal Products.
They must also be registered on the Australian Register of Therapeutic
Goods prior to sale on the Australian market. A preliminary to registration
is that the manufacturing site and systems be approved by the TGA which
often requires a visit from a TGA auditor. The visit is sponsored by
the company being audited and attracts an audit fee. Alternatively the
Health Authority in the country of origin can certify the manufacturing
company to TGA standards providing an Exchange Audit agreement exists
between the two countries.
The pharmaceutical industry is highly regulated on a worldwide basis,
with many countries requiring proof of operation to international standards
of GMP compliance before allowing products to be sold. Consequently
it is imperative that any manufacturing or packaging plant meets Australian
TGA GMP requirements if products are to be registered and distributed
in Australia.
INTERNATIONAL
GMP RECOGNITION . . .
The TGA operates to international standards and Australia is a member
nation of the EU's Pharmaceutical Inspection Convention Scheme (PICS)
having demonstrated acceptable legislative and audit processes to EU
standards.
Presently, no international accreditation scheme exists for the manufacture
of therapeutic goods other than PICS. PICS status can be obtained by
meeting the Australian TGA GMP requirements. Essentially this means
that the manufacturing and/or packaging sites meet world GMP criteria,
and it is the first step in gaining marketing authorisation in Australia
(and the other member nations).
This does not obviate the need to satisfy the various regulatory requirements
for product registration in each country, but it does simplify the approval
process for the
company's manufacturing sites.
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