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Manufacturing for biologicals

Understand the requirements for manufacturing biologicals.

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.

Good Manufacturing Practice

Understand the standards for Good Manufacturing Practice.

GMP clearance

Access information on applying for GMP clearance.

  • GMP pre-submission meetings

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    Information on requesting a pre-submission meeting with the TGA for planned Good Manufacturing Practice (GMP) Licensing, Certification and Clearance applications.

  • Overseas manufacturers

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    Sponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.

Licensing

Find out how to apply for, vary or maintain a manufacturing licence.

Certification

Access information on applying for or varying certification.

Inspections

Learn how TGA conducts inspections of manufacturing sites.

Product types