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.

Contents 

• GMP clearance basics
• Sponsor responsibilities
• How GMP Clearance is obtained
• How much GMP clearance costs
• How long GMP clearance takes
• The GMP clearance process
• Maintaining your active GMP clearance
• Transferring your GMP clearance
• Re-instatement of expired GMP clearance
• Cancellation, suspension, additional conditions, or reduction in scope by TGA
• GMP Compliance Signals 
• Identifying what documentation is required