Active Pharmaceutical Ingredients - Australian Organisation for Quality
Active Pharmaceutical Ingredients - Australian Organisation for Quality
Active Pharmaceutical Ingredients - Australian Organisation for Quality
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API Manufacture in Australia<br />
Special Challenges<br />
• Biotechnology Product Complexities<br />
– Closed system, “sterile” manufacturing<br />
process<br />
– Some process equipment can not be<br />
sterilised, requires sanitisation<br />
– Inherent API heterogeneity & highly complex<br />
analytical methods<br />
– Manufacturing process is integral part of<br />
product quality definition
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