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GMP Edition April 2008
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March 2007
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Manufacturing and GMP of medicines and medical devices
Manufacturers of medicines need to be licensed by the TGA or, if overseas, cleared by the TGA before the products they make can be supplied in Australia.
If you are a manufacturer we can:
- Advise on manufacturing processes and procedures according to the Australian and international Codes of GMP;
- Provide a pre-audit of your facilities;
- Help implement quality systems in manufacturing plants;
- Assist with appropriate responses to problems raised in GMP inspections.
If you are a sponsor of products manufactured by another company we can:
- Help you set up quality systems to ensure the ongoing quality of your products;
- Advise on whether your contracts with manufacturers of active pharmaceutical ingredients, intermediate and finished products meet regulatory requirements;
- Conduct inspections of manufacturing sites to GMP standard;
- Advise on quality problems.
Contact us for more information.
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