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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

Book pagination

Version history

Version Description of change Author Effective date
17th Edition Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for Overseas manufacturers Office of Manufacturing Quality 12/05/2011
V18.0 Updated title to GMP clearance guidance
Restructured to be more readable
Added instructions for submitting GMP clearance applications
Manufacturing Quality Branch
Regulatory Guidance Team
September 2017

Added fee table in GMP clearance basics section

Clarified that separate applications are required for each unique site address in the TGA database

Provided additional information regarding alternative or supplementary information to be provided upfront where applicable and the application receipting process

Clarified when applications would be removed from the system due to non-payment and the criteria for immediate not issue of GMP clearances for the MRA pathway

Provided additional information and illustrations around GMP agreements

Clarified for cell banking activities, names of specific cell lines are not required to be entered in the application

Provided additional information for extension applications

Added troubleshooting section

Minor editorial changes

Manufacturing Quality Branch January 2019

Book pagination