GMP clearance guidance

Version 18.3, June 2019

26 June 2019

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.

GMP clearance guidance

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Contents

  • GMP clearance basics
  • Step 1 - Understanding your supply chain and establishing agreements
  • Step 2 - Identifying the appropriate GMP clearance pathway
  • Step 3 - Identifying what documentation is required
  • Step 4 - Creating your application
  • Step 5 - Selecting your scope
  • Step 6 - Providing your evidence
  • Step 7 - Submitting your complete application and paying fees
  • Step 8 - Application receipt
  • Step 9 - Application assessment
  • Step 10 - Making a determination and assigning expiry dates
  • Step 11 - Maintaining your active GMP clearance
  • Transferring your GMP clearance
  • Withdrawing GMP clearance applications no longer required
  • Cancellation or reduction in scope by TGA
  • Evidence naming conventions
  • How to create a zip file
  • Keep up to date
  • Troubleshooting