How to obtain GMP clearance through inspection reliance

Note: the title of this information has changed from 'GMP Clearance Guidance' to 'How to obtain GMP clearance through inspection reliance'.

This information 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 information 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.