GMP clearance guidance
This guidance is for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site used in the manufacture of a medicine, or an Active Pharmaceutical Ingredient (API) used in a medicine, intended for supply in Australia.
This guidance is not intended for sponsors of:
- biologicals, human blood and blood components and Haematopoietic Progenitor Cells (HPCs), because Australia has its own manufacturing standard for these product types; however, where the manufacturing site performs only sterilisation of these product types, this guidance may be used
- some complementary and listed medicines, including sunscreens, because these may not be regulated as medicines in other countries
- Further information is available in the Australian manufacturing licences and overseas GMP certification guidance.