TGA updates GMP Clearance Guidance

19 September 2017

An updated guidance on GMP Clearance processes has been developed in consultation with the TGA Industry Working Group on GMP (TIWGG), to provide additional clarity and support for sponsors and applicants.

The updated guidance and associated webpages was published in September 2017 and is now available on the Manufacturing therapeutic goods pages of the TGA website.

The existing process guidelines have been archived and will no longer be accessible.

We have also published a new web-based GMP Clearance Application Assistance Tool (CAAT) to provide further assistance to sponsors and applicants prior to submitting GMP clearance applications.

We strongly encourage you to familiarise yourselves with, and start using, the new GMP clearance guidance and CAAT tool as soon as possible.

Enquiries and feedback

The TGA welcomes feedback that helps processes be improved. We would welcome any feedback you have on the updated GMP clearance guidance and CAAT tool. You can find our contact details here.