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Active Pharmaceutical Ingredients - Australian Organisation for Quality

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API Manufacture in Australia<br />

Special Challenges<br />

• Natural Product Complexities<br />

– Natural Products variable by their nature<br />

– Special requirements<br />

• eg. pesticides, herbicides <strong>for</strong> plant materials<br />

– Process understanding requires advanced<br />

chemistry & engineering know-how<br />

– Robust manufacturing processes required to<br />

produce consistent quality<br />

– Contamination control / sterility <strong>for</strong> tissue<br />

derived materials

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