GMP Clearance Guidance Update - Version 18.1

As part of our on-going review and improvement of existing guidance material, we have published an updated version of the GMP Clearance Guidance (v18.1). The update was developed using feedback received from industry either directly to us or through the TGA Industry Working Group on GMP (TIWGG). Some of the updates included are: The introduction of...

As part of our on-going review and improvement of existing guidance material, we have published an updated version of the GMP Clearance Guidance (v18.1).

The update was developed using feedback received from industry either directly to us or through the TGA Industry Working Group on GMP (TIWGG).

Some of the updates included are:

  • The introduction of a fee table for different application types
  • Further guidance around GMP, quality or technical agreements
  • Further guidance around the information required for extension applications
  • Introduction of a keep up to date section
  • Introduction of a trouble shooting section

The existing version of the guidance will be archived and will no longer be accessible.

We strongly encourage you to familiarise yourselves with, and start using the updated version of the GMP clearance guidance.

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.

You can find our contact details at: Contact details for enquiries about manufacturing therapeutic goods.

Source: www.tga.gov.au