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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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2: Complying with the manufacturing principles

Manufacturers need to comply with:

We provide information to help you comply with the regulatory requirements. You can also obtain advice from independent consultants and advisors.

We will monitor your compliance when we conduct the inspection.

Manufacturers need to comply with the manufacturing principles specified in Australian legislation. We recommend you seek independent legal advice to ensure you comply with all relevant requirements.

Some countries are not members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The manufacturing principles these countries' regulators inspect against may not be the same as those mandated in Australia.

Manufacturing principles

Identify the manufacturing principles that apply to your therapeutic goods.

The manufacturing principles are specified in the current Therapeutic Goods (Manufacturing Principles) Determinations. The codes of GMP specified in the manufacturing principles are different for:

Medicines and biologicals that contain live animal cells, tissues or organs

The PIC/S guide to GMP (except for annexes 4, 5, 14 and 16) is specified in the legislated manufacturing principles for medicines and biologicals that comprise or contain live animal cells tissues or organs.

Every manufacturing step for all medicine product types and dosage forms, at all sites, must be GMP compliant, unless there is an exemption. You can find examples of GMP compliance deficiencies on our website.

This also applies for biologicals that comprise or contain live animal cells, tissues or organs.

Human blood, blood components, Haematopoietic Progenitor Cells (HPCs) and biologicals that comprise, contain or are derived from human cells and tissues, or are specified as a biological by the Secretary

The Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products is specified in the legislated manufacturing principles for:

Unless there is an exemption, every manufacturing step must be GMP compliant for all product types and dosage forms, at all sites, for:

  • biologicals that comprise, contain or are derived from human cells and tissues, or are specified as a biological by the Secretary,
  • human blood and blood components
  • HPCs
You can find examples of GMP compliance deficiencies on our website.

Therapeutic Goods Orders

Check the Therapeutic Goods Orders to identify those relevant to your goods.

Default standards

Therapeutic goods that are not medical devices must comply with the applicable standards unless granted exemption. The default standards are the pharmacopoeias defined in Section 3 of the Therapeutic Goods Act 1989.

TGA guidance

To help you comply with the regulatory requirements, we provide guidance on manufacturing:

Independent advice

If you have no previous experience with manufacturing or sponsoring a therapeutic good in Australia, you may wish to seek the services of a GMP or regulatory affairs consultant.

We recommend you seek independent legal advice to ensure you comply with all relevant requirements.

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