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Manufacturing medicines

18 May 2021

This section is for the manufacture of medicines. You should also see Manufacturing basics and Manufacturing inspections, which include information for manufacturing of all types of therapeutic goods.

For blood, blood components and HPCs go to Manufacturing blood and blood components.

The Good Manufacturing Practice application decision tree can help you in determining if GMP licencing, certification or clearance is required.

Licence and GMP certification

Licence and overseas GMP certification applications

Revoking manufacturing licences

GMP clearance

Legislation & codes of practice

Section 36 of the Therapeutic Goods Act 1989 allows the Minister for Health to determine Manufacturing Principles that are to be applied in the manufacture of therapeutic goods

GMP guidance

The TGA has developed specific guidance for certain types of medicines. These offer pragmatic guidance on how compliance with GMP principles may be achieved.

We will be working with industry representatives and manufacturers to update all relevant technical guidance documents as a result of the adoption of the PIC/S Guide to GMP PE009-13. These documents will be completed and available during the transition phase (i.e. prior to 1 January 2019).

In the interim period, TGA inspectors will accept compliance with existing guidance documentation published on the TGA website.

GMP guidance for all medicines

Sterile medicines

Listed and complementary medicine GMP guidance

Specific medicines