Consultants to the Pharmaceutical and Healthcare Industries
4 Sharan Place, Forestville  Sydney  NSW  2087  Australia
Enquiries: (61- 2) 9975 6205  Facsimile: (61- 2) 9975 6209  email:eden@zipworld.com.au






                                                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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