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Source: Australian Department of Health

As part of our on-going process improvement activities and following consultation with the TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG) we have published GMP Clearance code tables guidance – Manufacturing steps (V1).

This guidance aims to assist sponsors when using the code tables for GMP Clearance applications by providing:

  • instructions on how to navigate the TGA Code Tables
  • interpretation of common manufacturing steps
  • information regarding validation rules within the various product registration or listing systems

We strongly encourage you to familiarise yourselves with, and start using the GMP Clearance code tables guidance – Manufacturing steps.

Enquiries and feedback

The TGA welcomes feedback that helps processes be improved. We would welcome any feedback you have on the above guidance.

To provide feedback on this or any items related to GMP Clearance please contact us.