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Manufacturing for prescription medicines

Understand our Good Manufacturing Practice regulations that apply to medicines. 

You must comply with regulatory requirements when manufacturing prescription medicines.  
 

Prescription medicines must be manufactured in accordance with legislated Good Manufacturing Practice (GMP). These standards ensure their quality, safety and efficacy. 
 

You are responsible for maintaining quality during production, supply, transport, and distribution.   
 

We regulate manufacturing to protect public health and ensure prescription medicines remain safe and effective.  
 

If you import or export prescription medicines, you must comply with Australian laws. 

  

You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to prescription medicines. You may also have to meet obligations that apply to all medicines and all products.

Good Manufacturing Practice

Understand the standards for Good Manufacturing Practice.

GMP clearance

Access information on applying for GMP clearance.

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.

  • GMP deficiencies

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    When we inspect a manufacturer for compliance with GMP, we assess your level of compliance with the manufacturing principles and any other requirements (such as TGOs and conditions of authorisation)

  • Manufacturer GMP compliance history

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    A manufacturer's compliance level is determined by the number and nature of deficiencies found during inspections, and their response to the inspection report.

  • Manufacturer inspections: an overview

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    Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards.
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