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