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You must comply with regulatory requirements when manufacturing biological products.
Biological products must be manufactured in compliance with recognised Good Manufacturing Practice (GMP) and product standards to ensure their quality, safety and efficacy.
These standards govern all aspects of production, testing, and release, with additional controls for biological variability and contamination risks.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. You may also have to meet obligations that apply to all products.